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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 K041164
Device Name L-TENS
Applicant
FUJI DYNAMICS LIMITED
UNIT 1-3, LAWS COMMERCIAL
PLAZA 788 CHEUNG SHA WAN RD.
HONG KONG,  CN
Applicant Contact ANTHONY AH YIN, SHUM
Correspondent
FUJI DYNAMICS LIMITED
UNIT 1-3, LAWS COMMERCIAL
PLAZA 788 CHEUNG SHA WAN RD.
HONG KONG,  CN
Correspondent Contact ANTHONY AH YIN, SHUM
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/03/2004
Decision Date 05/20/2004
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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