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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 K022076
Device Name FIRST CHOICE & FIRST CHOICE PLUS
Applicant
BODY CLOCK HEALTH CARE LTD
108 GEORGE LANE
SOUTH WOODFORD, LONDON,  GB E18 1AD
Applicant Contact JONATHAN BASH
Correspondent
BODY CLOCK HEALTH CARE LTD
108 GEORGE LANE
SOUTH WOODFORD, LONDON,  GB E18 1AD
Correspondent Contact JONATHAN BASH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/26/2002
Decision Date 09/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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