Disposable Procedural Ear-loop Face Mask

Mask, Surgical

Changzhou DSB Medical Co., LTD

The following data is part of a premarket notification filed by Changzhou Dsb Medical Co., Ltd with the FDA for Disposable Procedural Ear-loop Face Mask.

Pre-market Notification Details

Device IDK211042
510k NumberK211042
Device Name:Disposable Procedural Ear-loop Face Mask
ClassificationMask, Surgical
Applicant Changzhou DSB Medical Co., LTD No. 98 Fumin Rd, Changzhou Economic Development Zone Changzhou,  CN 213025
ContactSunny Han
CorrespondentMandy Wu
Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Century Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-08
Decision Date2021-07-15

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