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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 STE 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
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