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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K212926
Device Name AllureTM Surgical Mask
Applicant
Allure Gift Wraps Private Limited
Plot # J-21, J Type Area, 1st Phase, Gidc
Vapi,  IN 396195
Applicant Contact Mohan Jairam Raisinghani
Correspondent
Allure Life Sciences, LLC
4hancock Ct., Basking Ridge,
New Jersey,  NJ  07920
Correspondent Contact Sharad Raisinghani
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/14/2021
Decision Date 09/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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