FDA 510(k) Application Details - K132226

Device Classification Name Plate, Fixation, Bone

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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
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Regulation Number 888.3030

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Classification Product Code HRS
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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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