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510(k) K170945

Device
Biodesign Staple Line Reinforcement
Applicant
Cook Biotech Incorporated
510(k) number
K170945
Product code
OXE  
Decision
Substantially Equivalent (SESE)
Decision date
2017-04-28
Date received
2017-03-30
Regulation
878.3300
Classification name
Mesh, Surgical, Collagen, Staple Line Reinforcement
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Perry W. Guinn
Address
1425 Innovation Pl. West Lafayette IN US 47906 47906

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OXE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153364Kerecis SecureMeshKerecis Limited2016-08-19
K030879VERITAS COLLAGEN MATRIXSynovis Surgical Innovations2003-04-24
K022044SURGISIS STAPLE LINE REINFORCEMENTCook Biotech, Inc.2002-08-23

Legacy Summary#

summary

FDA Review#

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