Motex Anti-Fog Surgical Face Mask

Mask, Surgical

Modern Healthcare Corp.

The following data is part of a premarket notification filed by Modern Healthcare Corp. with the FDA for Motex Anti-fog Surgical Face Mask.

Pre-market Notification Details

Device IDK201549
510k NumberK201549
Device Name:Motex Anti-Fog Surgical Face Mask
ClassificationMask, Surgical
Applicant Modern Healthcare Corp. NO. 751, Sec. 2, Chung-Chou Rd., Tien-chung Town, Chang-hwa County,  TW 52045
ContactKe-min Jen
CorrespondentKe-min Jen
Chinese European Industrial Research Society No. 58, Fu-Chiun St Hsin-chu City,  TW 30067
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-09
Decision Date2020-08-26

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