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FDA 510(k) Application Details - K030378
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
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510(K) Number
K030378
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49087 US
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Contact
WADE T RUTKOSKIE
Other 510(k) Applications for this Contact
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
02/05/2003
Decision Date
03/20/2003
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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