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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 K103087
Device Name COVAMAX RESORBABLE COLLAGEN MEMBRANE
Applicant
BIOM'UP SAS
8, ALLEE IRENE JOLIOT-CURIE
ST-PRIEST,  FR 69800
Applicant Contact VALERIE CENTIS
Correspondent
BIOM'UP SAS
8, ALLEE IRENE JOLIOT-CURIE
ST-PRIEST,  FR 69800
Correspondent Contact VALERIE CENTIS
Regulation Number872.3930
Classification Product Code
NPL  
Date Received10/19/2010
Decision Date 08/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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