PERI-STRIPS Dry Staple Line Reinforcement With VERITAS Collagen Matrix With SECURE GRIP Technology

Mesh, Surgical

Synovis Life Technologies. Inc. (A Subsidiary Of Baxter

The following data is part of a premarket notification filed by Synovis Life Technologies. Inc. (a Subsidiary Of Baxter with the FDA for Peri-strips Dry Staple Line Reinforcement With Veritas Collagen Matrix With Secure Grip Technology.

Pre-market Notification Details

Device IDK213125
510k NumberK213125
Device Name:PERI-STRIPS Dry Staple Line Reinforcement With VERITAS Collagen Matrix With SECURE GRIP Technology
ClassificationMesh, Surgical
Applicant Synovis Life Technologies. Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Ave. W St. Paul,  MN  55114
ContactMegan Sajjad
CorrespondentMegan Sajjad
Synovis Life Technologies. Inc. (A Subsidiary Of Baxter International Inc.) 2575 University Ave. W St. Paul,  MN  55114
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-27
Decision Date2021-10-27

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