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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone grafting material, synthetic
510(k) Number K083742
Device Name SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
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
LYC  
Subsequent Product Code
NPM  
Date Received12/16/2008
Decision Date 02/12/2009
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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