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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K090522
Device Name OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
Applicant
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact ALMA RELJA
Correspondent
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact ALMA RELJA
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/26/2009
Decision Date 07/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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