Altor Safety 4-Ply Surgical Mask (Model:62232)

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 4-ply Surgical Mask (model:62232).

Pre-market Notification Details

Device IDK211762
510k NumberK211762
Device Name:Altor Safety 4-Ply Surgical Mask (Model:62232)
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)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-08
Decision Date2021-09-03

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