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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K030921
Device Name COLLAGEN TOPICAL WOUND DRESSING
Applicant
Collagen Matrix, Inc.
509 Commerce St.
Franklin Lakes,  NJ  07417
Applicant Contact PEGGY HANSEN
Correspondent
Collagen Matrix, Inc.
509 Commerce St.
Franklin Lakes,  NJ  07417
Correspondent Contact PEGGY HANSEN
Classification Product Code
KGN  
Date Received03/24/2003
Decision Date 05/15/2003
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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