Impertech Surgical Face Mask

Mask, Surgical

Impertech Industries Ltd.

The following data is part of a premarket notification filed by Impertech Industries Ltd. with the FDA for Impertech Surgical Face Mask.

Pre-market Notification Details

Device IDK212046
510k NumberK212046
Device Name:Impertech Surgical Face Mask
ClassificationMask, Surgical
Applicant Impertech Industries Ltd. 20 Derech Barkan St. Barkan,  IL 4482000
ContactMohamad Khweis
CorrespondentVaibhav Arvind Rajal
mdi Consultants Inc 55 Northern Blvd, Suite 200 Great Neck,  NY  11021
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-30
Decision Date2021-11-18

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