INTRODE INT-8

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 Introde Int-8.

Pre-market Notification Details

Device IDK930242
510k NumberK930242
Device Name:INTRODE INT-8
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant NEUROMED, INC. 5000-A OAKES RD., SUITE A Ft. Lauderdale,  FL  33314
ContactDean E Ciporkin
CorrespondentDean E Ciporkin
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 Received1993-01-19
Decision Date1994-02-02

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