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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 K942631
Device Name ELECTROCARE
Applicant
WACO CORP.
1069 VIA VERDE
SAN DIMAS,  CA  91773
Applicant Contact DANIEL DE TOUR
Correspondent
WACO CORP.
1069 VIA VERDE
SAN DIMAS,  CA  91773
Correspondent Contact DANIEL DE TOUR
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/03/1994
Decision Date 10/27/1995
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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