Surgical Face Masks (Ear Loops And Tie-On)

Mask, Surgical

San-M Package Co., Ltd.

The following data is part of a premarket notification filed by San-m Package Co., Ltd. with the FDA for Surgical Face Masks (ear Loops And Tie-on).

Pre-market Notification Details

Device IDK221534
510k NumberK221534
Device Name:Surgical Face Masks (Ear Loops And Tie-On)
ClassificationMask, Surgical
Applicant San-M Package Co., Ltd. 1086-1 Ojiro Shimada-city,  JP 428-8652
ContactAkihiko Goto
CorrespondentTakahiro Haruyama
Globizz Corporation 1411 W 190th St. Toyota Plaza #200 Gardena,  CA  90248
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-27
Decision Date2022-09-16

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