IMask Disposable Surgical Face Mask

Mask, Surgical

Pac-Dent, Inc.

The following data is part of a premarket notification filed by Pac-dent, Inc. with the FDA for Imask Disposable Surgical Face Mask.

Pre-market Notification Details

Device IDK201182
510k NumberK201182
Device Name:IMask Disposable Surgical Face Mask
ClassificationMask, Surgical
Applicant Pac-Dent, Inc. 670 Endeavor Circle Brea,  CA  92821
ContactJiahe Li
CorrespondentJiahe Li
Pac-Dent, Inc. 670 Endeavor Circle Brea,  CA  92821
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2021-02-19

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