FDA.report

510(k) K083266

Device
GORE BIO-A FISTULA PLUG
Applicant
W.L. GORE & ASSOCIATES,INC
510(k) number
K083266
Product code
FTL  
Decision
Substantially Equivalent (SESE)
Decision date
2009-03-27
Date received
2008-11-05
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
BARBARA L SMITH
Address
301 Airport Rd. Elkton MD US 21921 21921

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
H373FP06163GORE BIO-A Fistula PlugW. L. Gore & Associates, Inc.2017-02-13

Legacy Summary

summary

FDA Review

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