NEUROMED TS8 TEST STIMULATOR

Stimulator, Spinal-cord, Implanted (pain Relief)

NEUROMED, INC.

The following data is part of a premarket notification filed by Neuromed, Inc. with the FDA for Neuromed Ts8 Test Stimulator.

Pre-market Notification Details

Device IDK903814
510k NumberK903814
Device Name:NEUROMED TS8 TEST STIMULATOR
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant NEUROMED, INC. 5000-A OAKES RD., SUITE A Ft. Lauderdale,  FL  33314
ContactJames B Mcfarland
CorrespondentJames B Mcfarland
NEUROMED, INC. 5000-A OAKES RD., SUITE A Ft. Lauderdale,  FL  33314
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-20
Decision Date1991-01-16

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