PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT

Mesh, Surgical, Polymeric

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Peri-strips Planar Configuration Staple Line Reinforcement.

Pre-market Notification Details

Device IDK942583
510k NumberK942583
Device Name:PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT
ClassificationMesh, Surgical, Polymeric
Applicant BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul,  MN  55113
ContactBruce A Macfarlane, Ph.d
CorrespondentBruce A Macfarlane, Ph.d
BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul,  MN  55113
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-01
Decision Date1994-07-08

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