Welspun Health Surgical Mask

Mask, Surgical

Welspun India Limited

The following data is part of a premarket notification filed by Welspun India Limited with the FDA for Welspun Health Surgical Mask.

Pre-market Notification Details

Device IDK211536
510k NumberK211536
Device Name:Welspun Health Surgical Mask
ClassificationMask, Surgical
Applicant Welspun India Limited Survey No. 719, Village: Versamedi, Tal: Anjar District:kutch,  IN 370 110
ContactSatyapriya Dash
CorrespondentManoj Zacharias
Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora,  IL  60504
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-18
Decision Date2021-09-01

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