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FDA 510(k) Application Details - K991860
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
More FDA Info for this Device
510(K) Number
K991860
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI, PA 19301 US
Other 510(k) Applications for this Company
Contact
SHERI L MUSGNUNG
Other 510(k) Applications for this Contact
Regulation Number
882.5330
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Classification Product Code
GXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/1999
Decision Date
07/20/1999
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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