Biodesign Staple Line Reinforcement

Mesh, Surgical, Collagen, Staple Line Reinforcement

Cook Biotech Incorporated

The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Biodesign Staple Line Reinforcement.

Pre-market Notification Details

Device IDK170945
510k NumberK170945
Device Name:Biodesign Staple Line Reinforcement
ClassificationMesh, Surgical, Collagen, Staple Line Reinforcement
Applicant Cook Biotech Incorporated 1425 Innovation Place West Lafayette,  IN  47906
ContactPerry W. Guinn
CorrespondentDaniela I. Changkuon
Cook Biotech Incorporated 1425 Innovation Place West Lafayette,  IN  47906
Product CodeOXE  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-30
Decision Date2017-04-28
Summary:summary

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