FDA 510(k) Application Details - K140592

Device Classification Name Table, Physical Therapy, Multi Function

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510(K) Number K140592
Device Name Table, Physical Therapy, Multi Function
Applicant CERAGEM INTERNATIONAL, INC.
1468 Harwell Avenue
Crofton, MD 21114 US
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Contact E.J. Smith
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Regulation Number 890.5880

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Classification Product Code JFB
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Date Received 03/07/2014
Decision Date 12/17/2014
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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