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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 K003591
Device Name TENSCARE, MODEL TENS XL-2
Applicant
Tenscare, Ltd.
76 Stockport Rd.
Timperley, Cheshire,  GB WA15 7SN
Applicant Contact BERNARD J TREMAINE
Correspondent
Tenscare, Ltd.
76 Stockport Rd.
Timperley, Cheshire,  GB WA15 7SN
Correspondent Contact BERNARD J TREMAINE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/21/2000
Decision Date 02/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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