Medical Surgical Mask

Mask, Surgical

Sichuan Pharmaceutical. Inc.

The following data is part of a premarket notification filed by Sichuan Pharmaceutical. Inc. with the FDA for Medical Surgical Mask.

Pre-market Notification Details

Device IDK210813
510k NumberK210813
Device Name:Medical Surgical Mask
ClassificationMask, Surgical
Applicant Sichuan Pharmaceutical. Inc. Sichuan Pharmaceutical. Inc. No. 18 Baiye Road, Hi-Tech West Zone Sichuan,  CN 611731
ContactYunrui Zhang
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-17
Decision Date2021-10-08

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