TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

Mesh, Surgical, Polymeric

Medtronic, Inc.

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

Pre-market Notification Details

Device IDK180030
510k NumberK180030
Device Name:TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
ClassificationMesh, Surgical, Polymeric
Applicant Medtronic, Inc. 8200 Coral Sea St. NE Mounds View,  MN  55112
ContactNancy Cameron
CorrespondentNancy Cameron
Medtronic, Inc. 8200 Coral Sea St. NE Mounds View,  MN  55112
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2018-01-03
Decision Date2018-04-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000101619 K180030 000
00763000101602 K180030 000
00763000307882 K180030 000
00763000307875 K180030 000

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