FDA.report

510(k) K132397

Device
GORE BIO-A WOUND MATRIX
Applicant
W. L. GORE & ASSOCIATES, INC.
510(k) number
K132397
Product code
FRO  
Decision
Substantially Equivalent (SESE)
Decision date
2014-05-07
Date received
2013-08-01
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound, Drug
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
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, RAC
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

Legacy Summary

summary

FDA Review

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