Disposable Medical Face Mask (DF3-001)

Mask, Surgical

Wellmed Dental Medical Supply Co., Ltd.

The following data is part of a premarket notification filed by Wellmed Dental Medical Supply Co., Ltd. with the FDA for Disposable Medical Face Mask (df3-001).

Pre-market Notification Details

Device IDK222697
510k NumberK222697
Device Name:Disposable Medical Face Mask (DF3-001)
ClassificationMask, Surgical
Applicant Wellmed Dental Medical Supply Co., Ltd. 301 Zhongxing Science And Technology Building,No.64, Xin’an 2nd Road, Baoan District Shenzhen,  CN
ContactTang Renxian
CorrespondentJarvis Wu
Shanghai Sungo Management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-07
Decision Date2022-11-04

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