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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 K031989
Device Name ORTRAUTEK ORTHOGNATHIC SYSTEM
Applicant
TEKKA
6512 BANNOCKBURN DRIVE
BETHESDA,  MD  20817
Applicant Contact FAYYAZ MEMON
Correspondent
TEKKA
6512 BANNOCKBURN DRIVE
BETHESDA,  MD  20817
Correspondent Contact FAYYAZ MEMON
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/27/2003
Decision Date 10/28/2003
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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