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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 K021618
Device Name OSA RIGID INTERNAL FIXATION 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
JEY  
Date Received05/16/2002
Decision Date 08/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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