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510(k) K022044

Device
SURGISIS STAPLE LINE REINFORCEMENT
Applicant
COOK BIOTECH, INC.
510(k) number
K022044
Product code
OXE  
Decision
Substantially Equivalent (SESE)
Decision date
2002-08-23
Date received
2002-06-24
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
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARK BLEYER
Address
3055 Kent Ave. 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
K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated2017-04-28
K153364Kerecis SecureMeshKerecis Limited2016-08-19
K030879VERITAS COLLAGEN MATRIXSynovis Surgical Innovations2003-04-24

Legacy Summary#

summary

FDA Review#

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