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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 K120787
Device Name MERETE LOCKING BONE PLATE SYSTEM III
Original Applicant
MERETE MEDICAL GMBH
99 purchase street
rye,  NY  10580
Original Contact donna coleman
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTY   HWC  
Date Received03/15/2012
Decision Date 11/27/2012
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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