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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 K003339
Device Name COLLAGEN PERIODONTAL MEMBRANE
Applicant
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES,,  NJ  07417
Applicant Contact SHU-TUNG LI
Correspondent
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES,,  NJ  07417
Correspondent Contact SHU-TUNG LI
Regulation Number872.3930
Classification Product Code
NPL  
Date Received10/25/2000
Decision Date 01/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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