Peri-Strips Dry With Veritas Collagen Matrix With Secure Grip Technology (PSDV-SG)

Mesh, Surgical

Synovis Life Technologies, Inc. (Baxter International Inc.)

The following data is part of a premarket notification filed by Synovis Life Technologies, Inc. (baxter International Inc.) with the FDA for Peri-strips Dry With Veritas Collagen Matrix With Secure Grip Technology (psdv-sg).

Pre-market Notification Details

Device IDK192615
510k NumberK192615
Device Name:Peri-Strips Dry With Veritas Collagen Matrix With Secure Grip Technology (PSDV-SG)
ClassificationMesh, Surgical
Applicant Synovis Life Technologies, Inc. (Baxter International Inc.) 2575 University Ave. W St. Paul,  MN  55114
ContactMegan Sajjad
CorrespondentMegan Sajjad
Synovis Life Technologies, Inc. (Baxter International Inc.) 2575 University Ave. W St. Paul,  MN  55114
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-23
Decision Date2019-12-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412658860 K192615 000
50085412658808 K192615 000
50085412658853 K192615 000
50085412658792 K192615 000

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