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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 K862337
Device Name ULTRAPAC II SD (TM)
Original Applicant
MEDICAL DEVICES, INC.
833 third st. southwest
st. paul,  MN  55112
Original Contact bruce macfarlane,phd
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/20/1986
Decision Date 08/18/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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