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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 K061022
Device Name BIO 1-KIT BIOSORB FILLED CARTRIDGE
Applicant
Science For Biomaterials
Zi Du Monge
Lourdes,  FR 65100
Applicant Contact DENIS CLEMENT
Correspondent
Science For Biomaterials
Zi Du Monge
Lourdes,  FR 65100
Correspondent Contact DENIS CLEMENT
Regulation Number888.3045
Classification Product Code
MQV  
Date Received04/13/2006
Decision Date 05/24/2006
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
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