MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022

Shunt, Central Nervous System And Components

MEDTRONIC PS MEDICAL

The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Polyurethane Shunt, Models 27521, 27116, 20022.

Pre-market Notification Details

Device IDK991502
510k NumberK991502
Device Name:MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
ClassificationShunt, Central Nervous System And Components
Applicant MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta,  CA  93117 -5500
ContactJeffrey Henderson
CorrespondentJeffrey Henderson
MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta,  CA  93117 -5500
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-29
Decision Date2000-09-12
Summary:summary

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