Altor Safety 3-Ply Surgical Mask (Model:62222)

Mask, Surgical

Altor Safety LLC

The following data is part of a premarket notification filed by Altor Safety Llc with the FDA for Altor Safety 3-ply Surgical Mask (model:62222).

Pre-market Notification Details

Device IDK211249
510k NumberK211249
Device Name:Altor Safety 3-Ply Surgical Mask (Model:62222)
ClassificationMask, Surgical
Applicant Altor Safety LLC 711 Executive Boulevard Suite C Valley Cottage,  NY  10989
ContactJared Scott
CorrespondentDallas L. Thomas
Thomas Regulatory Resolutions, Inc. 1069 Piccadilly St. Palm Beach Gardens,  FL  33418
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-07-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G023622222Z2 K211249 000
G023622221 K211249 000

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