FDA.report

510(k) K955556

Device
FLUID RESISTANT MASK
Applicant
AMERICAN THRESHOLD HEALTHCARE
510(k) number
K955556
Product code
FXX  
Decision
Substantially Equivalent (SESE)
Decision date
1996-04-25
Date received
1995-12-05
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
FRANCES MAYHEW
Address
P.O. Box 1209 240 Sardis Rd. Enka NC US 28728 28728

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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