Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name mask, surgical
510(k) Number K210147
Device Name Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield
Applicant
Unicoglobal, Inc.
#904, Woolim Pangyo W-City 9-22, Pangyo-Ro 255bion-Gil
Bundang-gu
Seongnam,  KR 13486
Applicant Contact Yoonsok Park
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt, STE 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/21/2021
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-