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FDA 510(k) Application Details - K100414
Device Classification Name
Pin, Fixation, Threaded
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510(K) Number
K100414
Device Name
Pin, Fixation, Threaded
Applicant
MERETE MEDICAL GMBH
ALT LANKWITZ 102
BERLIN 12247 DE
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EMMANUEL ANAPLIOTIS
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Regulation Number
888.3040
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Classification Product Code
JDW
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More FDA Info for this Product Code
Date Received
02/16/2010
Decision Date
07/02/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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