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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 K141764
Device Name TRISTAR BONE GRAFT FIXATION SYSTEM
Applicant
Impladent , Ltd.
198-45 Foothill Ave.
Hollis,  NY  11423
Applicant Contact MAURICE VALEN
Correspondent
Impladent , Ltd.
198-45 Foothill Ave.
Hollis,  NY  11423
Correspondent Contact MAURICE VALEN
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received07/01/2014
Decision Date 12/18/2014
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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