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510(k) K010936

Device
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Applicant
W.L. GORE & ASSOCIATES,INC
510(k) number
K010936
Product code
OXD  
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-21
Date received
2001-03-28
Regulation
878.3300
Classification name
Mesh, Surgical, Non-absorbable, 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
R. LARRY PRATT
Address
3450 W. Kiltie Ln. Flagstaff AZ US 86002 86002

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OXD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001789SEAMGUARD STAPLE LINE REINFORCEMENT MATERIALW. L. Gore & Associates, Inc.2000-07-06
K955364SEAMGUARD STAPLE LINE REINFORCEMENT MATERIALW. L. Gore & Associates, Inc.1996-02-01

Legacy Summary#

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FDA Review#

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