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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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