Single-use Surgical Mask

Mask, Surgical

BYD Precision Manufacturer Co.Ltd.

The following data is part of a premarket notification filed by Byd Precision Manufacturer Co.ltd. with the FDA for Single-use Surgical Mask.

Pre-market Notification Details

Device IDK200923
510k NumberK200923
Device Name:Single-use Surgical Mask
ClassificationMask, Surgical
Applicant BYD Precision Manufacturer Co.Ltd. No.3001 Baohe Road, Baolong Industrial Area, Longgang Shenzhen,  CN 518116
ContactYubo Guan
CorrespondentAnnie Zhang
Nova Clinical Solutions, Inc. 6792 Solterra Vista Pkwy San Diego,  CA  92130
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-07
Decision Date2020-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000
00850022724169 K200923 000

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