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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 K990944
Device Name OSTEOMED INTRAORAL DISTRACTION SYSTEM
Applicant
Osteomed Corp.
3750 Realty Rd.
Addison,  TX  75001
Applicant Contact RICK A BUSS
Correspondent
Osteomed Corp.
3750 Realty Rd.
Addison,  TX  75001
Correspondent Contact RICK A BUSS
Regulation Number872.4760
Classification Product Code
MQN  
Date Received03/22/1999
Decision Date 06/16/1999
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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