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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K121578
Device Name ATOM 1 (MODEL: BRC 2200)
Applicant
Bioelectric Research Corporation
112 N. Curry St.
Carson City,  NV  89703
Applicant Contact STEVEN KAYE
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact PAULA WILKERSON, RAC, CRA
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/30/2012
Decision Date 07/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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