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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K091208
Device Name GS III SYSTEM
Applicant
OSSTEM IMPLANT CO.,LTD
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Applicant Contact MINJOO KIM
Correspondent
OSSTEM IMPLANT CO.,LTD
85 BEN FAIRLESS DR.
FAIRLESS HILLS,  PA  19030
Correspondent Contact MINJOO KIM
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/24/2009
Decision Date 03/03/2010
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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