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FDA 510(k) Application Details - K152076
Device Classification Name
Plate, Cranioplasty, Preformed, Alterable
More FDA Info for this Device
510(K) Number
K152076
Device Name
Plate, Cranioplasty, Preformed, Alterable
Applicant
Stryker
750 TRADE CENTRE WAY
SUITE 200
PORTAGE, MI 49002 US
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Contact
Jonathan Schell
Other 510(k) Applications for this Contact
Regulation Number
882.5320
More FDA Info for this Regulation Number
Classification Product Code
GWO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/27/2015
Decision Date
08/26/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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