Cufitec Surgical Mask

Surgical Mask With Antimicrobial/antiviral Agent

NBC Meshtec Inc.

The following data is part of a premarket notification filed by Nbc Meshtec Inc. with the FDA for Cufitec Surgical Mask.

Pre-market Notification Details

Device IDK182766
510k NumberK182766
Device Name:Cufitec Surgical Mask
ClassificationSurgical Mask With Antimicrobial/antiviral Agent
Applicant NBC Meshtec Inc. 2-50-3 Toyoda Hino,  JP 191-0053
ContactTomokazu Nagao
CorrespondentTakahiro Haruyama
Globizz Corporation 1411 W. 190th St. Suite 200 Gardena,  CA  90248
Product CodeOUK  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-28
Decision Date2019-01-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860006561826 K182766 000

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