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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 K041575
Device Name FENZIAN TREATMENT SYSTEM
Applicant
EUMEDIC LIMITED
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Applicant Contact LEWIS W WARD
Correspondent
EUMEDIC LIMITED
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Correspondent Contact LEWIS W WARD
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/14/2004
Decision Date 07/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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