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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 K173093
Device Name TAMA BEMS device
Applicant
Tama Research Corporation
7600 N. 16th St.,
Suite 205
Phoenix,  AZ  85020
Applicant Contact Ali Shambayati
Correspondent
Medical Devices Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05728
Correspondent Contact Robert Packard
Regulation Number882.5890
Classification Product Code
NFO  
Date Received09/29/2017
Decision Date 06/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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