FDA.report

510(k) K070644

Device
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
Applicant
W. L. GORE & ASSOCIATES, INC.
510(k) number
K070644
Product code
FTL  
Decision
Substantially Equivalent (SESE)
Decision date
2007-04-02
Date received
2007-03-08
Regulation
878.3300
Classification name
Mesh, Surgical, Polymeric
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
BARBARA L SMITH
Address
301 Airport Rd. P.O. Box 1408 Elkton MD US 21922 21922

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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