FDA 510(k) Application Details - K031576

Device Classification Name Orthosis, Limb Brace

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510(K) Number K031576
Device Name Orthosis, Limb Brace
Applicant SURGITECH, INC.
2424 VISTA WAY, SUITE 300
OCEANSIDE, CA 92054 US
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Contact CHRISTOPHER CROWELL
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Regulation Number 890.3475

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Classification Product Code IQI
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Date Received 05/20/2003
Decision Date 07/31/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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