8-CHANNEL MULTIPROG IMPLANT SPINAL CORD 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 8-channel Multiprog Implant Spinal Cord Stimulator.

Pre-market Notification Details

Device IDK860158
510k NumberK860158
Device Name:8-CHANNEL MULTIPROG IMPLANT SPINAL CORD STIMULATOR
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant NEUROMED, INC. P.O. BOX 290010 Davies,  FL  33329
ContactFrank Liska
CorrespondentFrank Liska
NEUROMED, INC. P.O. BOX 290010 Davies,  FL  33329
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-16
Decision Date1986-03-07

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