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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 K201323
Device Name INNO SLA Submerged Implant System
Applicant
Cowellmedi Co., Ltd.
48, Hakgam-Daero 221beon-Gil, Sasang-Gu
Busan,  KR 46986
Applicant Contact Minjin Park
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/18/2020
Decision Date 01/25/2022
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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