Single-use Surgical Mask

Mask, Surgical

Taiwan Seafood And Fish Corporation

The following data is part of a premarket notification filed by Taiwan Seafood And Fish Corporation with the FDA for Single-use Surgical Mask.

Pre-market Notification Details

Device IDK211773
510k NumberK211773
Device Name:Single-use Surgical Mask
ClassificationMask, Surgical
Applicant Taiwan Seafood And Fish Corporation 733 Gladys Avenue Los Angeles,  CA  90021
ContactEric Ly
CorrespondentEric Ly
Taiwan Seafood And Fish Corporation 733 Gladys Avenue Los Angeles,  CA  90021
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-08
Decision Date2021-12-02

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