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FDA 510(k) Application Details - K121624
Device Classification Name
Plate, Cranioplasty, Preformed, Alterable
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510(K) Number
K121624
Device Name
Plate, Cranioplasty, Preformed, Alterable
Applicant
BIOMET MICROFIXATION
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 US
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Contact
SHERYL MALMBERG
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Regulation Number
882.5320
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Classification Product Code
GWO
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More FDA Info for this Product Code
Date Received
06/01/2012
Decision Date
10/12/2012
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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