MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS

Shunt, Central Nervous System And Components

VYGON US LLC

The following data is part of a premarket notification filed by Vygon Us Llc with the FDA for Modification To Lumbo-peritoneal Shunts And Lumbar Drainage Catheters.

Pre-market Notification Details

Device IDK033704
510k NumberK033704
Device Name:MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
ClassificationShunt, Central Nervous System And Components
Applicant VYGON US LLC 2495 GENERAL ARMSTEAD AVE. Norristown,  PA  19403
ContactCourtney Smith
CorrespondentCourtney Smith
VYGON US LLC 2495 GENERAL ARMSTEAD AVE. Norristown,  PA  19403
Product CodeJXG  
CFR Regulation Number882.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-25
Decision Date2004-05-27

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