Surgical Mask

Mask, Surgical

Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Safesecure Medical Infection Control Tech Co., Ltd with the FDA for Surgical Mask.

Pre-market Notification Details

Device IDK213358
510k NumberK213358
Device Name:Surgical Mask
ClassificationMask, Surgical
Applicant Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd 6A01, Block 1, Ahoke Plaza, Daling Community, Minzhi Street, Longhua District Shenzhen,  CN 518109
ContactPatty Chen
CorrespondentEva Li
Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500# Century Ave Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-12
Decision Date2022-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06973563061815 K213358 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.