FDA.report

510(k) K032865

Device
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
Applicant
W. L. GORE & ASSOCIATES, INC.
510(k) number
K032865
Product code
FTL  
Decision
Substantially Equivalent (SESE)
Decision date
2003-11-28
Date received
2003-09-12
Regulation
878.3300
Classification name
Mesh, Surgical, Polymeric
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MIKE JOHNSON
Address
3450 W. Kiltie Ln. Flagstaff AZ US 86001 86001

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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