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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 K994266
Device Name FDTENS 2010
Applicant
Fuji Dynamics Limited
Unit 103, 23/F, Laws Plaza
788 Cheung Sha Wan Rd.
Kowloon,  HK
Applicant Contact TORU HORIUCHI
Correspondent
Fuji Dynamics Limited
Unit 103, 23/F, Laws Plaza
788 Cheung Sha Wan Rd.
Kowloon,  HK
Correspondent Contact TORU HORIUCHI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/17/1999
Decision Date 07/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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