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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 K945676
Device Name GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES
Applicant
SELECTIVE MED COMPONENTS, INC.
208 W. HIGH ST.
MT. VERNON,  OH  43050
Applicant Contact RICHARD J FISHER, JR
Correspondent
SELECTIVE MED COMPONENTS, INC.
208 W. HIGH ST.
MT. VERNON,  OH  43050
Correspondent Contact RICHARD J FISHER, JR
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
GXY  
Date Received11/18/1994
Decision Date 01/30/1995
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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