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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K112351
Device Name ULTRA BEAUTY
Applicant
JOHARI DIGITAL HEALTHCARE, LTD.
ELECTRONIC HARDWARE TECHNOLOGY
PARK, G-582-584, E.P.I.P
BORANADA, JODHPUR, RAJASTHAN,  IN 342008
Applicant Contact POOJA JOHARI
Correspondent
JOHARI DIGITAL HEALTHCARE, LTD.
ELECTRONIC HARDWARE TECHNOLOGY
PARK, G-582-584, E.P.I.P
BORANADA, JODHPUR, RAJASTHAN,  IN 342008
Correspondent Contact POOJA JOHARI
Regulation Number882.5890
Classification Product Code
NFO  
Date Received08/16/2011
Decision Date 03/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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