The IMask Child's Face Mask

Pediatric/child Facemask

Pac-Dent, Inc.

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

Pre-market Notification Details

Device IDK202831
510k NumberK202831
Device Name:The IMask Child's Face Mask
ClassificationPediatric/child Facemask
Applicant Pac-Dent, Inc. 670 Endeavor Circle Brea,  CA  92821
ContactJiahe Li
CorrespondentDong He
Pac-Dent, Inc. 670 Endeavor Circle Brea,  CA  92821
Product CodeOXZ  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-25
Decision Date2021-08-26

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