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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K232546
Device Name Meta G UCLA Abutment
Applicant
Cowellmedi Co., Ltd.
48, Hakgam-daero 221beon-gil, Sasang-gu
Busan,  KR 46986
Applicant Contact Haejun Lee
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave STE 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/23/2023
Decision Date 11/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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