Disposable Surgical Face Mask

Mask, Surgical

Shandong Aida Medical Products Co., Ltd

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

Pre-market Notification Details

Device IDK220302
510k NumberK220302
Device Name:Disposable Surgical Face Mask
ClassificationMask, Surgical
Applicant Shandong Aida Medical Products Co., Ltd Wangjiazhuang, Wangliu Strret Office, Weicheng District Weifang,  CN 261053
ContactWang Bing
CorrespondentWang Bing
Shandong Aida Medical Products Co., Ltd Wangjiazhuang, Wangliu Street Office, Weicheng District Weifang,  CN 261053
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-02
Decision Date2022-11-16

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