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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K964468
Device Name IAMIN WET DRESSING (COPPER-SALINE)
Applicant
Procyte Corp.
12040 115th Ave. NE
Suite 210
Kirkland,  WA  98034
Applicant Contact PAUL KETTERIDGE
Correspondent
Procyte Corp.
12040 115th Ave. NE
Suite 210
Kirkland,  WA  98034
Correspondent Contact PAUL KETTERIDGE
Classification Product Code
MGQ  
Date Received11/06/1996
Decision Date 02/03/1997
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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