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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 K874818
Device Name TENSTAR
Applicant
Healthcheck Corp.
150 Sandbank Rd.
Cheshire,  CT  06410
Applicant Contact BALZER, JR.
Correspondent
Healthcheck Corp.
150 Sandbank Rd.
Cheshire,  CT  06410
Correspondent Contact BALZER, JR.
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/24/1987
Decision Date 09/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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