FDA.report

510(k) K150551

Device
GORE SEAMGUARD Reinforcement
Applicant
W. L. GORE & ASSOCIATES, INC.
510(k) number
K150551
Product code
OXC  
Decision
Substantially Equivalent (SESE)
Decision date
2015-03-30
Date received
2015-03-04
Regulation
878.3300
Classification name
Mesh, Surgical, Absorbable, 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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
BARBARA L. SMITH
Address
1505 N Fourth St. Flagstaff AZ US 86004 86004

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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