ASM-301 Level 3 Surgical Mask

Mask, Surgical

American Surgical Mask Company LLC

The following data is part of a premarket notification filed by American Surgical Mask Company Llc with the FDA for Asm-301 Level 3 Surgical Mask.

Pre-market Notification Details

Device IDK211440
510k NumberK211440
Device Name:ASM-301 Level 3 Surgical Mask
ClassificationMask, Surgical
Applicant American Surgical Mask Company LLC 5508 N 50th Street Suite 1000 Tampa,  FL  33610
ContactMatt Brandman
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 Received2021-05-10
Decision Date2021-06-02

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