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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 K142496
Device Name Collagen Dental Membrane - Conformable IIBP
Applicant
COLLAGEN MATRIX, INC.
15 THORNTON ROAD
OAKLAND,  NJ  07436
Applicant Contact GLORIA ZUCLICH
Correspondent
COLLAGEN MATRIX, INC.
15 THORNTON ROAD
OAKLAND,  NJ  07436
Correspondent Contact GLORIA ZUCLICH
Regulation Number872.3930
Classification Product Code
NPL  
Date Received09/05/2014
Decision Date 11/24/2014
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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