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FDA 510(k) Application Details - K053199
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
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510(K) Number
K053199
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER, PA 19380 US
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Contact
Lisa Boyle
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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
11/16/2005
Decision Date
12/14/2005
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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