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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 K880492
Device Name INTERCEPT T.E.N.S. DEVICE
Applicant
MEDICAL DESIGN & MANUFACTURING CORP.
929 EASTWIND DR.
WESTERVILLE,  OH  43081
Applicant Contact MICHAEL SOUTHWORTH
Correspondent
MEDICAL DESIGN & MANUFACTURING CORP.
929 EASTWIND DR.
WESTERVILLE,  OH  43081
Correspondent Contact MICHAEL SOUTHWORTH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/04/1988
Decision Date 04/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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