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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 K062881
Device Name COLLAGEN DENTAL MENBRANE - CONFORMABLE II
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
Regulation Number872.3930
Classification Product Code
NPL  
Date Received09/26/2006
Decision Date 10/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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