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FDA 510(k) Application Details - K152420
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
NGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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