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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 K010203
Device Name ACCU-PULSE TENS UNIT
Applicant
SADLER ELECTRONICS
3 COETZENBERG ROAD
EDGEMEAD,  ZA 7441
Applicant Contact C A SADLER
Correspondent
SADLER ELECTRONICS
3 COETZENBERG ROAD
EDGEMEAD,  ZA 7441
Correspondent Contact C A SADLER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/22/2001
Decision Date 08/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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