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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K120818
Device Name OTIS-C PLUS
Applicant
Science For Biomaterials
Zi Du Monge
Lourdes,  FR F 65100
Applicant Contact DENIS CLEMENT
Correspondent
Science For Biomaterials
Zi Du Monge
Lourdes,  FR F 65100
Correspondent Contact DENIS CLEMENT
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/19/2012
Decision Date 04/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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