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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K141909
Device Name COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
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
Regulation Number872.3930
Classification Product Code
NPL  
Date Received07/15/2014
Decision Date 11/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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