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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, nerve conduction velocity measurement
510(k) Number K884663
Device Name IMPULSE EPIDURAL ELECTRODE
Applicant
IMPULSE SYSTEMS, INC.
124 VISTA RD.
MADISON,  WI  53705
Applicant Contact RAYMOND T RIDDLE
Correspondent
IMPULSE SYSTEMS, INC.
124 VISTA RD.
MADISON,  WI  53705
Correspondent Contact RAYMOND T RIDDLE
Regulation Number882.1550
Classification Product Code
JXE  
Date Received11/07/1988
Decision Date 01/17/1989
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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