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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K020735
Device Name SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
Applicant
Cathay International, Ltd.
Rm. 8f-3, # 29, Chungshan N.
Rd. Sec 3
Taipei,  TW
Applicant Contact ANNE JEN
Correspondent
Cathay International, Ltd.
Rm. 8f-3, # 29, Chungshan N.
Rd. Sec 3
Taipei,  TW
Correspondent Contact ANNE JEN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/06/2002
Decision Date 07/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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