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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(K) Number K102688
Device Name MERETE LOCKING BONE PLATE SYSTEM II
Applicant
MERETE MEDICAL GMBH
49 purchase street
rye,  NY  10580
Contact emmanuel anapliotis
Regulation Number888.3030
Classification Product Code
KTT  
Date Received09/17/2010
Decision Date 12/03/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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