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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K143730
Device Name GBR System
Applicant
Jeil Medical Corporation
702-706, 804, 805,807,812-Ho ,55, Digital-Ro 34-Gil,
Guro-Gu
Seoul,  KR 152-728
Applicant Contact HYEROUNG LEE
Correspondent
Jeil Medical Corporation
702-706, 804, 805,807,812-Ho ,55, Digital-Ro 34-Gil,
Guro-Gu
Seoul,  KR 152-728
Correspondent Contact HYEROUNG LEE
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received12/29/2014
Decision Date 06/10/2015
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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