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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 K150965
Device Name LeForte System II
Applicant
Jeil Medical Corporation
702, 703, 704, 705, 706, 804, 805,807,812-ho ,55,
Digital-ro34-gil, Guro-gu
Seoul-City,  KR 152-728
Applicant Contact Jieun KIM
Correspondent
LK Consulting Group USA, Inc.
2651 East Chapman Avenue, Suite 110
Fullerton,  CA  92831
Correspondent Contact PRISCILLA CHUNG
Regulation Number872.4760
Classification Product Code
JEY  
Date Received04/10/2015
Decision Date 09/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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