FDA.report

510(k) K143124

Device
KA01 Chitosan Wound Dressing
Applicant
FOSHAN UNITED MEDICAL TECHNOLOGIES LTD.
510(k) number
K143124
Product code
FRO  
Decision
Substantially Equivalent (SESE)
Decision date
2015-01-26
Date received
2014-10-31
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
JOHN CEN
Address
89 Taoyuan E. Rd. Shishan, Nanhai, Foshan CN 528225 528225

FDA Registration Numbers

Source Documents

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

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Legacy Summary

summary

FDA Review

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