FDA.report

510(k) K172500

Device
Technoweb Surgical Mask
Applicant
YTS GLOBAL INC.
510(k) number
K172500
Product code
FXX  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-01
Date received
2017-08-18
Regulation
878.4040
Classification name
Mask, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
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
Eddie Nguyen
Address
7406 Alban Station Ct. Suite A108 Springfield VA US 22150 22150

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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