MEDAMICUS EPIDURAL INTRODUCER

Stimulator, Spinal-cord, Implanted (pain Relief)

MEDAMICUS, INC.

The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Medamicus Epidural Introducer.

Pre-market Notification Details

Device IDK994097
510k NumberK994097
Device Name:MEDAMICUS EPIDURAL INTRODUCER
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis,  MN  55447
ContactDennis Manson
CorrespondentDennis Manson
MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis,  MN  55447
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-03
Decision Date2000-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994748027 K994097 000

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