NEOVEIL Staple Line Reinforcement

Mesh, Surgical, Absorbable, Staple Line Reinforcement

Gunze Limited

The following data is part of a premarket notification filed by Gunze Limited with the FDA for Neoveil Staple Line Reinforcement.

Pre-market Notification Details

Device IDK221487
510k NumberK221487
Device Name:NEOVEIL Staple Line Reinforcement
ClassificationMesh, Surgical, Absorbable, Staple Line Reinforcement
Applicant Gunze Limited 46 Natsumegaichi, Aono Ayabe, Kyoto,  JP 623-8513
ContactHidenori Nishioka
CorrespondentStuart R. Goldman
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeOXC  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-23
Decision Date2022-08-26

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