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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name external mandibular fixator and/or distractor
510(k) Number K031708
Device Name OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM
Applicant
OSTEOMED L.P.
3885 ARAPAHO RD.
ADDISON,  TX  75001
Applicant Contact DAWN T HOLDERMAN
Correspondent
OSTEOMED L.P.
3885 ARAPAHO RD.
ADDISON,  TX  75001
Correspondent Contact DAWN T HOLDERMAN
Regulation Number872.4760
Classification Product Code
MQN  
Date Received06/02/2003
Decision Date 11/03/2003
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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