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FDA 510(k) Application Details - K123723
Device Classification Name
Plate, Cranioplasty, Preformed, Alterable
More FDA Info for this Device
510(K) Number
K123723
Device Name
Plate, Cranioplasty, Preformed, Alterable
Applicant
SYNTHES
1301 Goshen Parkway
West Chester, PA 19380 US
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Contact
ALAN T HALEY
Other 510(k) Applications for this Contact
Regulation Number
882.5320
More FDA Info for this Regulation Number
Classification Product Code
GWO
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More FDA Info for this Product Code
Date Received
12/04/2012
Decision Date
09/05/2013
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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