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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K183475
Device Name T1-CS, T1-C
Applicant
Osstem Implant Co., Ltd.
2 Floor, B-Dong, 51, Mayu-Ro 238beon-Gil
Siheung-Si,  KR 15079
Applicant Contact Jiyoon Ha
Correspondent
Hiossen, Inc.
85 Ben Fairless Dr.
Fariless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/17/2018
Decision Date 08/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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