PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18

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 Percutaneous Introducer Set, Model 042294 And Kit Model 3550-18.

Pre-market Notification Details

Device IDK013120
510k NumberK013120
Device Name:PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis,  MN  55447
ContactDennis S Madison
CorrespondentDennis S Madison
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 Received2001-09-18
Decision Date2002-01-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994729989 K013120 000
20613994393054 K013120 000
00643169660076 K013120 000

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