Iamin Wet Dressing (Copper-Saline)

• • Terminated Z-1516-2015 FDA Class II ·initiated 26 Mar 2015

  The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearance to market these devices.

510(k) Number

K964468 ↗

FDA Product Code

MGQ

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Iamin Impregnated Gauze Dressing

  Unclassified

  FDA 510(k) K965005 Active Cleared 24 Feb 1997

• Osmocyte Ultra/Pe Pillow Wound Dressing

  Class I

  FDA 510(k) K962623 Active Cleared 26 Nov 1996

• Osmocyte Island Wound Dressing

  Class I

  FDA 510(k) K972150 Active Cleared 10 Dec 1997

• Lamin-2 Hydrating Gel

  Unclassified

  FDA 510(k) K970153 Active Cleared 5 Jun 1997

• Iamin Gel Wound Dressing

  Unclassified

  FDA 510(k) K953853 Active Cleared 5 Feb 1996

• Osmocyte Wound Manager Sheet Dressing

  Unclassified

  FDA 510(k) K965143 Active Cleared 22 May 1997

See all devices from Procyte Corp. →