QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF

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 Quadra Cath Elect(3mm Sizes) 1990j, Jf, Jp + Jpf.

Pre-market Notification Details

Device IDK852920
510k NumberK852920
Device Name:QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant NEUROMED, INC. 5000 A OAKES RD. STE.A. Ft. Lauderdale,  FL  33314
ContactFrank Liska
CorrespondentFrank Liska
NEUROMED, INC. 5000 A OAKES RD. STE.A. Ft. Lauderdale,  FL  33314
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-10
Decision Date1985-10-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.