FDA 510(k) Application Details - K092731

Device Classification Name Table, Physical Therapy, Multi Function

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510(K) Number K092731
Device Name Table, Physical Therapy, Multi Function
Applicant PNEUMEX, INC.
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN, TX 78746 US
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Contact JEAN ASQUITH
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Regulation Number 890.5880

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Classification Product Code JFB
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Date Received 09/04/2009
Decision Date 06/10/2010
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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