Disposable Medical Surgical Mask

Mask, Surgical

Hebei Titans Hongsen Medical Technology Co., LTD

The following data is part of a premarket notification filed by Hebei Titans Hongsen Medical Technology Co., Ltd with the FDA for Disposable Medical Surgical Mask.

Pre-market Notification Details

Device IDK212097
510k NumberK212097
Device Name:Disposable Medical Surgical Mask
ClassificationMask, Surgical
Applicant Hebei Titans Hongsen Medical Technology Co., LTD Eastern Industrial Concentration Zone, Nangong City Xingtai,  CN 055750
ContactChai Wu
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing,  CN 102401
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-06
Decision Date2021-08-18

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