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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 K013672
Device Name BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM
Applicant
Azary Technologies, LLC
P.O. Box 2156
Huntington,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
Azary Technologies, LLC
P.O. Box 2156
Huntington,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number872.4760
Classification Product Code
JEY  
Date Received11/06/2001
Decision Date 04/08/2002
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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