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FDA 510(k) Application Details - K013050
Device Classification Name
Plate, Cranioplasty, Preformed, Non-Alterable
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510(K) Number
K013050
Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Applicant
BIOPLATE, INC.
6911 MELROSE AVE.
LOS ANGELES, CA 90038 US
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Contact
CAROL E JONES
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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
09/11/2001
Decision Date
12/10/2001
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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