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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K092780
FOIA Releasable 510(k) K092780
Device Name INF 4160 PLUS, MODEL D-FJ31F
Applicant
FUJI DYNAMICS LIMITED
23/F., UNIT 1-3,
788 CHEUNG SHA WAN ROAD
KOWLOON, HONG KONG,  CN
Applicant Contact CHING KONG LEE
Correspondent
FUJI DYNAMICS LIMITED
23/F., UNIT 1-3,
788 CHEUNG SHA WAN ROAD
KOWLOON, HONG KONG,  CN
Correspondent Contact CHING KONG LEE
Regulation Number882.5890
Classification Product Code
LIH  
Date Received09/10/2009
Decision Date 01/07/2010
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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