FDA 510(k) Application Details - K022273

Device Classification Name Orthosis, Cranial

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510(K) Number K022273
Device Name Orthosis, Cranial
Applicant BEVERLY HILLS PROSTHETICS ORTHOTICS, INC.
6300 WILSHIRE BLVD., SUITE 150
LOS ANGELES, CA 90048-5203 US
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Contact KEITH E VINNECOUR
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Regulation Number 882.5970

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Classification Product Code MVA
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Date Received 07/15/2002
Decision Date 09/09/2002
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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