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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 K212303
Device Name T2
Applicant
Osstem Implant Co., Ltd.
2 Floor, B-dong, 51, Mayu-ro 238beon-gil
Siheung-si,  KR 15079
Applicant Contact Jinwoo Bae
Correspondent
Hiossen Inc.
85 Ben Fairless Dr.
Fairless Hills,  PA  19030
Correspondent Contact Peter Lee
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/23/2021
Decision Date 09/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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