PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED

Mesh, Surgical

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Peri-strips-sleeve, Peri-strips-strip And Peri-strips Dry (non-naoh-treated And Naoh-treated.

Pre-market Notification Details

Device IDK992537
510k NumberK992537
Device Name:PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
ClassificationMesh, Surgical
Applicant BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
ContactMary Kay Kessinger Sobcinski
CorrespondentMary Kay Kessinger Sobcinski
BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul,  MN  55114 -1024
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-29
Decision Date2000-02-22
Summary:summary

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