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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 K955453
Device Name ACTICOAT SILVER COATED DRESSING
Applicant
WESTAIM TECHNOLOGIES, INC.
555 13TH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
WESTAIM TECHNOLOGIES, INC.
555 13TH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received11/29/1995
Decision Date 05/31/1996
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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