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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K971612
Device Name OSMO/PCA PILLOW WOUND DRESSING
Applicant
PROCYTE CORP.
12040 115TH AVENUE NE
SUITE 210
KIRKLAND,  WA  98034 -6900
Applicant Contact PAUL KETTERIDGE
Correspondent
PROCYTE CORP.
12040 115TH AVENUE NE
SUITE 210
KIRKLAND,  WA  98034 -6900
Correspondent Contact PAUL KETTERIDGE
Regulation Number880.5090
Classification Product Code
KMF  
Date Received05/02/1997
Decision Date 03/16/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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