FDA 510(k) Application Details - K960307

Device Classification Name Device, Warning, Overload, External Limb, Powered

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510(K) Number K960307
Device Name Device, Warning, Overload, External Limb, Powered
Applicant ORTHOPEDIC TECHNOLOGY RESEARCH, INC.
819 WEST STRYKER AVE.
SUITE 10
SACRAMENTO, CA 95834 US
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Contact BRIAN T CLEARY
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Regulation Number 890.5575

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Classification Product Code IRN
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Date Received 01/22/1996
Decision Date 06/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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