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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 K970153
Device Name LAMIN-2 HYDRATING GEL
Applicant
Procyte Corp.
12040 115th Ave. NE, #210
Kirkland,  WA  98034
Applicant Contact PAUL KETTERIDGE
Correspondent
Procyte Corp.
12040 115th Ave. NE, #210
Kirkland,  WA  98034
Correspondent Contact PAUL KETTERIDGE
Classification Product Code
MGQ  
Date Received01/16/1997
Decision Date 06/05/1997
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
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