Surgical Mask

Mask, Surgical

Sichuan Prius Biotechnology Co., Ltd.

The following data is part of a premarket notification filed by Sichuan Prius Biotechnology Co., Ltd. with the FDA for Surgical Mask.

Pre-market Notification Details

Device IDK210908
510k NumberK210908
Device Name:Surgical Mask
ClassificationMask, Surgical
Applicant Sichuan Prius Biotechnology Co., Ltd. No.2 Prius Road, Luo Long Industrial Park Nanxi District Yibin,  CN 644104
ContactYan Liu
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2021-09-26

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