INTAI Surgical Mask (non-sterile)

Mask, Surgical

INTAI Technology Corp.

The following data is part of a premarket notification filed by Intai Technology Corp. with the FDA for Intai Surgical Mask (non-sterile).

Pre-market Notification Details

Device IDK210422
510k NumberK210422
Device Name:INTAI Surgical Mask (non-sterile)
ClassificationMask, Surgical
Applicant INTAI Technology Corp. No. 9, Jingke Rd., Nantun Dist.,  TW 40852
ContactDale Chang
CorrespondentKevin Wang
INTAI Technology Corp. No. 9, Jingke Rd., Nantun District Taichung,  TW 40852
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-11
Decision Date2022-03-30

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