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FDA 510(k) Application Details - K132226
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K132226
Device Name
Plate, Fixation, Bone
Applicant
MERETE MEDICAL GMBH
102 ALT LANKWITZ
BERLIN D-12247 DE
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Contact
EMMANUEL ANAPLIOTIS
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/17/2013
Decision Date
08/09/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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