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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, Battery-Powered
510(k) Number K904025
Device Name MYOTRACK, MODEL HH 515
Applicant
MYOTRACK CO.
P.O. BOX 56025
VAN NUYS,  CA  91413
Applicant Contact FREDERIC P TORRES
Correspondent
MYOTRACK CO.
P.O. BOX 56025
VAN NUYS,  CA  91413
Correspondent Contact FREDERIC P TORRES
Regulation Number868.2775
Classification Product Code
BXN  
Date Received08/30/1990
Decision Date 03/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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