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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 K173120
Device Name CCM Abutment System
Applicant
InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu
Daejeon,  KR 34027
Applicant Contact Bo-reum Yoo
Correspondent
Withus Group Inc
2531 Pepperdale Drive
Rowland Heights,  CA  91748
Correspondent Contact April Lee
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/29/2017
Decision Date 03/16/2018
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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