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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 K931570
Device Name COM-TENS (SINGLE MODE)
Applicant
Ems Dist.
P.O. Drawer 179
Pen Valley,  CA  95946
Applicant Contact THOMAS V DAIGLE`
Correspondent
Ems Dist.
P.O. Drawer 179
Pen Valley,  CA  95946
Correspondent Contact THOMAS V DAIGLE`
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/30/1993
Decision Date 06/18/1993
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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