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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, smooth
510(k) Number K112197
Device Name MEMOMETAL INTRA-MEDULLARY BONE FASTENER
Applicant
MEMOMETAL TECHNOLOGIES
CAMPUS DE KER LANN
RUE BLAISE PASCAL
BRUZ,  FR F35170
Applicant Contact GILLES AUDIC
Correspondent
MEMOMETAL TECHNOLOGIES
CAMPUS DE KER LANN
RUE BLAISE PASCAL
BRUZ,  FR F35170
Correspondent Contact GILLES AUDIC
Regulation Number888.3040
Classification Product Code
HTY  
Date Received08/01/2011
Decision Date 11/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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