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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 K902102
Device Name COM-TENS: A NEUROSTIMULATOR
Applicant
Apex Medical, Inc.
P.O. Drawer 179
Pen Valley,  CA  95946
Applicant Contact THOMAS DAIGLE
Correspondent
Apex Medical, Inc.
P.O. Drawer 179
Pen Valley,  CA  95946
Correspondent Contact THOMAS DAIGLE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/08/1990
Decision Date 05/30/1991
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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