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FDA 510(k) Application Details - K153559
Device Classification Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
More FDA Info for this Device
510(K) Number
K153559
Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Applicant
Accelerated Care Plus (ACP)
4999 Aircenter Circle, Ste. 103
Reno, NV 89502 US
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Contact
Patrick Parker
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Regulation Number
890.5860
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Classification Product Code
IMG
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More FDA Info for this Product Code
Date Received
12/14/2015
Decision Date
08/26/2016
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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