SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

Mesh, Surgical, Non-absorbable, Staple Line Reinforcement

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 Staple Line Reinforcement Material.

Pre-market Notification Details

Device IDK955364
510k NumberK955364
Device Name:SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
ClassificationMesh, Surgical, Non-absorbable, Staple Line Reinforcement
Applicant W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P. O. BOX 500 Flagstaff,  AZ  86002 -0500
ContactR. Larry Pratt
CorrespondentR. Larry Pratt
W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P. O. BOX 500 Flagstaff,  AZ  86002 -0500
Product CodeOXD  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-22
Decision Date1996-02-01
Summary:summary

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