Good Afternoon,
Smith and nephew is baaaaccccckkkk! This new device is cost effective, user friendly and utilizes the soft port technology. It will take the market by storm. Watch for yourself.....
Smith & Nephew Medical, Ltd. c/o Ms. Laura Reynolds Smith & Nephew, Inc. 970 Lake Carillon Dr., Suite 110 St. Petersburg, FL 33716 Re: K153209 Trade/Device Name: RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCHCanisters, RENASYS TOUCHCarry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IVPole/Bed Clamp, RENASYSTOUCH Class 2 Power Supply Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: July 1, 2016 Received: July 5, 2016 Dear Ms. Reynolds:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Smith and nephew is baaaaccccckkkk! This new device is cost effective, user friendly and utilizes the soft port technology. It will take the market by storm. Watch for yourself.....
Smith & Nephew Medical, Ltd. c/o Ms. Laura Reynolds Smith & Nephew, Inc. 970 Lake Carillon Dr., Suite 110 St. Petersburg, FL 33716 Re: K153209 Trade/Device Name: RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCHCanisters, RENASYS TOUCHCarry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IVPole/Bed Clamp, RENASYSTOUCH Class 2 Power Supply Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: July 1, 2016 Received: July 5, 2016 Dear Ms. Reynolds:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.