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FDA 510(k) Application Details - K160707
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
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510(K) Number
K160707
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
FIN-CERAMICA FAENZA SPA
via ravegnana 186
Faenza 48018 IT
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Contact
Monticelli Marina
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Regulation Number
882.5330
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Classification Product Code
GXN
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More FDA Info for this Product Code
Date Received
03/14/2016
Decision Date
12/17/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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