TYRX Neuro Absorbable Antibacterial Envelope

Mesh, Surgical, Polymeric

MEDTRONIC TYRX, INC.

The following data is part of a premarket notification filed by Medtronic Tyrx, Inc. with the FDA for Tyrx Neuro Absorbable Antibacterial Envelope.

Pre-market Notification Details

Device IDK150291
510k NumberK150291
Device Name:TYRX Neuro Absorbable Antibacterial Envelope
ClassificationMesh, Surgical, Polymeric
Applicant MEDTRONIC TYRX, INC. 1 DEER PARK DRIVE SUITE G Monmouth Junction,  NJ  08852
ContactRegina Novak
CorrespondentRegina Novak
MEDTRONIC TYRX, INC. 1 DEER PARK DRIVE SUITE G Monmouth Junction,  NJ  08852
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2015-02-06
Decision Date2015-03-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169983540 K150291 000
00643169983533 K150291 000
00643169624795 K150291 000
00643169624788 K150291 000

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