SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

Mesh, Surgical

W. L. GORE & ASSOCIATES, INC.

The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Seamguard Bioabsorbable Staple Line Reinforcement Material.

Pre-market Notification Details

Device IDK030782
510k NumberK030782
Device Name:SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
ClassificationMesh, Surgical
Applicant W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff,  AZ  86001
ContactMike Johnson
CorrespondentMike Johnson
W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff,  AZ  86001
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-11
Decision Date2003-04-21
Summary:summary

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