FDA 510(k) Application Details - K152420

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K152420
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant AK BEAUTY ENTERPRISES, LLC
436 NORTH BEDFORD DRIVE
SUITE 203
BEVERLY HILLS, CA 90210 US
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Contact Robert Applebaum
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 08/26/2015
Decision Date 12/01/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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