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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 K854317
Device Name MINIPAC (TM)
Applicant
MEDICAL DEVICES, INC.
833 THIRD ST. SOUTHWEST
ST. PAUL,  MN  55112
Applicant Contact BRUCE A MACFARLANE
Correspondent
MEDICAL DEVICES, INC.
833 THIRD ST. SOUTHWEST
ST. PAUL,  MN  55112
Correspondent Contact BRUCE A MACFARLANE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/28/1985
Decision Date 01/21/1986
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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