The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surg

Mask, Surgical

The GOOD Corporation

The following data is part of a premarket notification filed by The Good Corporation with the FDA for The Good High Fluid-resistant Surgical Mask, The Good High Fluid-resistant Surgical Procedure Kf Mask, The Good Super Guard Design High Fluid-resistant Surgical Mask, The Koeasy High Fluid-resistant Surgical Mask, The Koeasy High Fluid-resistant Surg.

Pre-market Notification Details

Device IDK211771
510k NumberK211771
Device Name:The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surg
ClassificationMask, Surgical
Applicant The GOOD Corporation 47-13 Eoso 3-gil, Cheongbuk-eup Pyeongtaek-si,  CN 17795
ContactHak Rae Lee
CorrespondentMikael Hellstrand
K-Bio Solutions 201 South 4th St, Suite 727 San Jose,  CA  95112
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-08
Decision Date2022-08-24

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