CiRx (R) Surgical Mask

Mask, Surgical

Ningbo Shun Ye Medical Company, Ltd.

The following data is part of a premarket notification filed by Ningbo Shun Ye Medical Company, Ltd. with the FDA for Cirx (r) Surgical Mask.

Pre-market Notification Details

Device IDK210256
510k NumberK210256
Device Name:CiRx (R) Surgical Mask
ClassificationMask, Surgical
Applicant Ningbo Shun Ye Medical Company, Ltd. No.5 Industry Road, Zhangqi Industry Zone, Cixi Ningbo,  CN 315313
ContactFrank Yu
CorrespondentFrank Yu
Ningbo Shun Ye Medical Company, Ltd. No.5 Industry Road, Zhangqi Industry Zone, Cixi Ningbo,  CN 315313
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-08-19

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