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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 K122115
Device Name COLLAGEN DENTAL WOUND DRESSINGS
Applicant
COLLAGEN MATRIX, INC.
15 THORNTON ROAD
OAKLAND,  NJ  07436
Applicant Contact PEGGY HANSEN
Correspondent
COLLAGEN MATRIX, INC.
15 THORNTON ROAD
OAKLAND,  NJ  07436
Correspondent Contact PEGGY HANSEN
Classification Product Code
KGN  
Date Received07/17/2012
Decision Date 11/01/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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