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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K103081
Device Name COVAORTHO-NERVE 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 Number882.5275
Classification Product Code
JXI  
Date Received10/19/2010
Decision Date 03/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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