Allmed Surgical Face Masks (Ear Loops)

Mask, Surgical

Allmed Medical Products Co., LTD

The following data is part of a premarket notification filed by Allmed Medical Products Co., Ltd with the FDA for Allmed Surgical Face Masks (ear Loops).

Pre-market Notification Details

Device IDK202128
510k NumberK202128
Device Name:Allmed Surgical Face Masks (Ear Loops)
ClassificationMask, Surgical
Applicant Allmed Medical Products Co., LTD No. 180 Gongyuan Road Majiadian Town Zhijiang,  CN 443200
ContactVince Tian
CorrespondentVince Tian
Allmed Medical Products Co., LTD No. 180 Gongyuan Road Majiadian Town Zhijiang,  CN 443200
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2021-06-03

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.