Dukal Corporation Level 2 Surgical Mask With Ear Loops; Dukal Corporation Level 2 Surgical Mask With Ear Loops And Face Shield; Dukal Corporation Level 2 Surgical Mask With Adjustable Tie Ons

Mask, Surgical

Dukal Corporation

The following data is part of a premarket notification filed by Dukal Corporation with the FDA for Dukal Corporation Level 2 Surgical Mask With Ear Loops; Dukal Corporation Level 2 Surgical Mask With Ear Loops And Face Shield; Dukal Corporation Level 2 Surgical Mask With Adjustable Tie Ons.

Pre-market Notification Details

Device IDK201421
510k NumberK201421
Device Name:Dukal Corporation Level 2 Surgical Mask With Ear Loops; Dukal Corporation Level 2 Surgical Mask With Ear Loops And Face Shield; Dukal Corporation Level 2 Surgical Mask With Adjustable Tie Ons
ClassificationMask, Surgical
Applicant Dukal Corporation 2 Fleetwood Court Ronkonkoma,  NY  11779
ContactMegan Quevedo
CorrespondentMegan Quevedo
Dukal Corporation 2 Fleetwood Court Ronkonkoma,  NY  11779
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-29
Decision Date2021-02-05

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