Unico High Performance Surgical Mask, Unico High Performance Surgical Mask With Face Shield

Mask, Surgical

Unicoglobal, Inc.

The following data is part of a premarket notification filed by Unicoglobal, Inc. with the FDA for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask With Face Shield.

Pre-market Notification Details

Device IDK210147
510k NumberK210147
Device Name:Unico High Performance Surgical Mask, Unico High Performance Surgical Mask With Face Shield
ClassificationMask, Surgical
Applicant Unicoglobal, Inc. #904, Woolim Pangyo W-City 9-22, Pangyo-Ro 255bion-Gil Bundang-gu Seongnam,  KR 13486
ContactYoonsok Park
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine,  CA  92620
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-21
Decision Date2021-12-22

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