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FDA 510(k) Application Details - K153456
Device Classification Name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5290
More FDA Info for this Regulation Number
Classification Product Code
IMJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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