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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 K013618
Device Name INTRAORAL MANDIBULAR DISTRACTION SYSTEM
Applicant
OSTEOMED CORP.
3750 REALTY RD.
ADDISON,  TX  75001 -4311
Applicant Contact DAWN T HOLDEMAN
Correspondent
OSTEOMED CORP.
3750 REALTY RD.
ADDISON,  TX  75001 -4311
Correspondent Contact DAWN T HOLDEMAN
Regulation Number872.4760
Classification Product Code
MQN  
Date Received11/05/2001
Decision Date 08/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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