Surgical Mask

Mask, Surgical

ReMade USA LLC

The following data is part of a premarket notification filed by Remade Usa Llc with the FDA for Surgical Mask.

Pre-market Notification Details

Device IDK212451
510k NumberK212451
Device Name:Surgical Mask
ClassificationMask, Surgical
Applicant ReMade USA LLC 2915 E Washington Blvd Los Angeles,  CA  90023
ContactDavid Durst
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-08-05
Decision Date2021-09-10

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