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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K021963
Device Name BIOSORB RESORBABLE VOID FILLER
Applicant
Sciences ET Bio Materiaux (Sbm)
Zi Du Monge
Lourdes,  FR F 65100
Applicant Contact DENIS CLEMENT
Correspondent
Sciences ET Bio Materiaux (Sbm)
Zi Du Monge
Lourdes,  FR F 65100
Correspondent Contact DENIS CLEMENT
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/14/2002
Decision Date 01/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
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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