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FDA 510(k) Application Details - K133082
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
More FDA Info for this Device
510(K) Number
K133082
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
OSTEOSYMBIONICS, LLC
1768 EAST 25TH STREET
SUITE 316
CLEVELAND, OH 44114 US
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Contact
NICHOLAS WLKINS
Other 510(k) Applications for this Contact
Regulation Number
882.5330
More FDA Info for this Regulation Number
Classification Product Code
GXN
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More FDA Info for this Product Code
Date Received
09/30/2013
Decision Date
05/20/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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