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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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