Disposable Surgical Face Mask

Mask, Surgical

XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD.

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

Pre-market Notification Details

Device IDK153496
510k NumberK153496
Device Name:Disposable Surgical Face Mask
ClassificationMask, Surgical
Applicant XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD. NO. 258 PENGCHANG ROAD, MIDDLE STREET Xiantao,  CN 433018
ContactLiang Zhang
CorrespondentRay Wang
Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd. Chaoyang District Beijing,  CN 100024
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-07
Decision Date2016-06-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60665973010375 K153496 000

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