Disposable Surgical Face Mask

Mask, Surgical

Shandong Zhushi Pharmaceutical Group Co., Ltd

The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd with the FDA for Disposable Surgical Face Mask.

Pre-market Notification Details

Device IDK210643
510k NumberK210643
Device Name:Disposable Surgical Face Mask
ClassificationMask, Surgical
Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd No.6 Shande Road, Shan County Heze,  CN 274300
ContactJunhui Zhu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-03
Decision Date2021-08-04

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