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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K203539
Device Name Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
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 Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number878.4040
Classification Product Code
FYA  
Date Received12/03/2020
Decision Date 12/10/2021
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
Predetermined Change
Control Plan Authorized		 No
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