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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, spinal-cord, implanted (pain relief)
510(k) Number K903814
Device Name NEUROMED TS8 TEST STIMULATOR
Original Applicant
NEUROMED, INC.
5000-a oakes rd., suite a
ft. lauderdale,  FL  33314
Original Contact james b mcfarland
Regulation Number882.5880
Classification Product Code
GZB  
Date Received08/20/1990
Decision Date 01/16/1991
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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