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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 K041359
Device Name BODY CLOCK STIMPLUS AND STIMPLUS PRO
Applicant
Body Clock Health Care, Ltd.
108 George Lane
South Woodford
London,  GB E18 1AD
Applicant Contact RASHELLE PRESTON
Correspondent
Body Clock Health Care, Ltd.
108 George Lane
South Woodford
London,  GB E18 1AD
Correspondent Contact RASHELLE PRESTON
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/21/2004
Decision Date 08/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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