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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Submucosal Injection Agent
510(k) Number K220434
Device Name Blue Eye (TS-905)
Applicant
The Standard Co., Ltd.
120, Gunpocheomdansaneop 2-Ro
Gunpo-Si,  KR 15880
Applicant Contact Sung Nam Kim
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave.
Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number876.1500
Classification Product Code
PLL  
Date Received02/15/2022
Decision Date 08/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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