DURAMESH Mesh Suture

Suture, Nonabsorbable, Synthetic, Polypropylene

MSi

The following data is part of a premarket notification filed by Msi with the FDA for Duramesh Mesh Suture.

Pre-market Notification Details

Device IDK211178
510k NumberK211178
Device Name:DURAMESH Mesh Suture
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant MSi One Magnificent Mile 980 N. Lake Shore Drive, Suite 1400 Chicago,  IL  60611
ContactGreg Dumanian
CorrespondentGreg Dumanian
MSi One Magnificent Mile 980 N. Lake Shore Drive, Suite 1400 Chicago,  IL  60611
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-20
Decision Date2022-09-02

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