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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K090091
Device Name OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
Applicant
Mylad Orthopedic Solutions, LLC
8803 Windy Creek Way
Mclean,  VA  22102
Applicant Contact SCOTT EDWARDS
Correspondent
Mylad Orthopedic Solutions, LLC
8803 Windy Creek Way
Mclean,  VA  22102
Correspondent Contact SCOTT EDWARDS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/14/2009
Decision Date 02/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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