FDA 510(k) Application Details - K971046

Device Classification Name Table, Physical Therapy, Multi Function

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510(K) Number K971046
Device Name Table, Physical Therapy, Multi Function
Applicant HANDIFLEX CORP.
4611 SOUTH UNIVERSITY DR.
SUITE 432
DAVIE, FL 33328 US
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Contact JOSE BRUNO ROMAN
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Regulation Number 890.5880

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Classification Product Code JFB
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Date Received 03/21/1997
Decision Date 09/16/1997
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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