Surgical Mask

Mask, Surgical

Changzhou Holymed Products Co., Ltd.

The following data is part of a premarket notification filed by Changzhou Holymed Products Co., Ltd. with the FDA for Surgical Mask.

Pre-market Notification Details

Device IDK210524
510k NumberK210524
Device Name:Surgical Mask
ClassificationMask, Surgical
Applicant Changzhou Holymed Products Co., Ltd. 525 Changwu Road South Changzhou,  CN 213167
ContactShan Shang
CorrespondentShan Shang
Changzhou Holymed Products Co., Ltd. 525 Changwu Road South Changzhou,  CN 213167
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-23
Decision Date2021-07-07

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