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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 K143338
Device Name Argulated Locking Plates
Applicant
OSTEOMED L.P.
3885 ARAPAHO RD.
ADDISON,  TX  75001
Applicant Contact Anita Zacherl
Correspondent
OSTEOMED L.P.
3885 ARAPAHO RD.
ADDISON,  TX  75001
Correspondent Contact Anita Zacherl
Regulation Number872.4760
Classification Product Code
JEY  
Date Received11/20/2014
Decision Date 04/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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