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 IDK160269
510k NumberK160269
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
ContactShogo Nagao
CorrespondentTakahiro Haruyama
Globizz Corporation 1411 W. 190th St. Toyota Plaza #200 Gardena,  CA  90248
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-02
Decision Date2016-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20386120010889 K160269 000
20386120010865 K160269 000
20386120010933 K160269 000

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