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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K141168
Device Name ANSISTIM
Applicant
Dyansys, Inc.
300, N. Bayshore Blvd.
San Mateo,  CA  94401
Applicant Contact SRINI NAGESHWAR
Correspondent
Dyansys, Inc.
300, N. Bayshore Blvd.
San Mateo,  CA  94401
Correspondent Contact SRINI NAGESHWAR
Classification Product Code
BWK  
Date Received05/06/2014
Decision Date 05/15/2015
Decision Substantially Equivalent (SESE)
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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