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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Adhesive, Closure, Skin
510(k) Number K946321
Device Name BIOSTRIP STERILE WOUND CLOSURE STRIP
Applicant
Cornelia Damsky, Inc.
56 Westcott Rd.
Stamford,  CT  06902
Applicant Contact CORNELIA DAMSKY
Correspondent
Cornelia Damsky, Inc.
56 Westcott Rd.
Stamford,  CT  06902
Correspondent Contact CORNELIA DAMSKY
Regulation Number880.5240
Classification Product Code
FPX  
Date Received12/28/1994
Decision Date 01/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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