Secure Wear USA Surgical Face Mask

Mask, Surgical

Secured Ortho Manufacturing Of America, LLC

The following data is part of a premarket notification filed by Secured Ortho Manufacturing Of America, Llc with the FDA for Secure Wear Usa Surgical Face Mask.

Pre-market Notification Details

Device IDK203101
510k NumberK203101
Device Name:Secure Wear USA Surgical Face Mask
ClassificationMask, Surgical
Applicant Secured Ortho Manufacturing Of America, LLC 28 West Jefryn Boulevard Suite C Deer Park,  NY  11729
ContactVincent Benenati
CorrespondentVincent Benenati
Secured Ortho Manufacturing Of America, LLC 28 West Jefryn Boulevard Suite C Deer Park,  NY  11729
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-14
Decision Date2021-03-31

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