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FDA 510(k) Application Details - K063395
Device Classification Name
Orthosis, Cranial
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510(K) Number
K063395
Device Name
Orthosis, Cranial
Applicant
ORTHOTIC & PROSTHETIC LAB, INC.
748 MARSHALL AVE.
WEBSTER GROVES, MO 63119 US
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Contact
THOMAS L MALONE
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Regulation Number
882.5970
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Classification Product Code
MVA
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More FDA Info for this Product Code
Date Received
11/09/2006
Decision Date
12/22/2006
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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