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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 K951689
Device Name TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM
Applicant
Medicon EG
24301 Roberts Dr., Suite C
Black Diamond,  WA  98010
Applicant Contact DENNIS YOUDE
Correspondent
Medicon EG
24301 Roberts Dr., Suite C
Black Diamond,  WA  98010
Correspondent Contact DENNIS YOUDE
Regulation Number872.4760
Classification Product Code
JEY  
Date Received04/05/1995
Decision Date 07/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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