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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 K063792
Device Name OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
Applicant
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact PIEDAD PENA
Correspondent
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact PIEDAD PENA
Regulation Number872.4760
Classification Product Code
MQN  
Date Received12/22/2006
Decision Date 03/02/2007
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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