Velguard Surgical Face Mask

Mask, Surgical

Estee Exports Health Care Division

The following data is part of a premarket notification filed by Estee Exports Health Care Division with the FDA for Velguard Surgical Face Mask.

Pre-market Notification Details

Device IDK210761
510k NumberK210761
Device Name:Velguard Surgical Face Mask
ClassificationMask, Surgical
Applicant Estee Exports Health Care Division 8/3176 A3 & A4, Jothipuram, 2nd Street, Pandian Nagar, PN Road Tirupur,  IN 641602
ContactZachary Wilson
CorrespondentAmy Fowler
Pathmaker FDA Law, PLLC 901 Twelve Oaks Center Drive Wayzata,  MN  55391
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2021-07-16

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