FDA 510(k) Application Details - K153456

Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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510(K) Number K153456
Device Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant Accelerated Care Plus
4999 Aircenter Circle, Suite 103
Reno, NV 89502 US
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Contact Patrick Parker
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Regulation Number 890.5290

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Classification Product Code IMJ
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Date Received 12/01/2015
Decision Date 06/14/2016
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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