Sterile Disposable Wet Skin Scrub Tray

• • Terminated Z-0268-2007 FDA Unclassified (pre-2012) ·initiated 21 Nov 2006

  The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.

510(k) Number

K914174 ↗

FDA Product Code

LRO

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SEKD

• Sterile Disposable Urine Collector & Accessories

  Class II

  FDA 510(k) K913223 Active Cleared 4 Sep 1991

• Central Venous Catheter Dressing Change Tray

  Class II

  FDA 510(k) K912158 Active Cleared 23 Oct 1991

• Major Basin Tray

  Class I

  FDA 510(k) K912104 Active Cleared 9 Aug 1991

• Shower Chairs

  Class I

  FDA 510(k) K922045 Active Cleared 26 May 1992

• Powermatic Treatment Table

  Class I

  FDA 510(k) K933581 Active Cleared 5 Nov 1993

• Latex Patient Examination Gloves

  Class I

  FDA 510(k) K911081 Active Cleared 21 Mar 1991

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