Skypro, SP02 Mask (3)

Mask, Surgical

Skypro Medical Supplies Company

The following data is part of a premarket notification filed by Skypro Medical Supplies Company with the FDA for Skypro, Sp02 Mask (3).

Pre-market Notification Details

Device IDK202255
510k NumberK202255
Device Name:Skypro, SP02 Mask (3)
ClassificationMask, Surgical
Applicant Skypro Medical Supplies Company C301, Tsing Yi Industrial Centre Phase 2, 1-33 Cheung Tat Road, Tsing Yi, N.T. Hong Kong,  CN
ContactCyrus Wong
CorrespondentCyrus Wong
Skypro Medical Supplies Company C301, Tsing Yi Industrial Centre Phase 2, 1-33 Cheung Tat Road, Tsing Yi, N.T. Hong Kong,  CN
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-10
Decision Date2021-12-24

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