AllureTM Surgical Mask

Mask, Surgical

Allure Gift Wraps Private Limited

The following data is part of a premarket notification filed by Allure Gift Wraps Private Limited with the FDA for Alluretm Surgical Mask.

Pre-market Notification Details

Device IDK212926
510k NumberK212926
Device Name:AllureTM Surgical Mask
ClassificationMask, Surgical
Applicant Allure Gift Wraps Private Limited Plot No. J-21, J Type Area, 1st Phase, GIDC Vapi,  IN 396195
ContactMohan Jairam Raisinghani
CorrespondentSharad Raisinghani
Allure Life Sciences LLC 4Hancock CT, Basking Ridge, New Jersey,  NJ  07920
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-14
Decision Date2022-09-16

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