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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 K102072
Device Name MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)
Applicant
Memometal Technologies
Rue Blaise Pascal
Campus De Ker Lann
Bruz,  FR 35170
Applicant Contact GILLES AUDIC
Correspondent
Memometal Technologies
Rue Blaise Pascal
Campus De Ker Lann
Bruz,  FR 35170
Correspondent Contact GILLES AUDIC
Regulation Number888.3040
Classification Product Code
HTY  
Date Received07/23/2010
Decision Date 11/03/2010
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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