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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 K080387
Device Name HU II / HS II FIXTURE SYSTEM
Applicant
Osstem Implant Co., Ltd.
1 Ben Fairless Dr.
Fairless,  PA  19030
Applicant Contact MIN JOO KIM
Correspondent
Osstem Implant Co., Ltd.
1 Ben Fairless Dr.
Fairless,  PA  19030
Correspondent Contact MIN JOO KIM
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/13/2008
Decision Date 03/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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