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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K093753
Device Name MDPO FRAME SYSTEM
Applicant
MDPO, LLC
901 KING ST.
SUITE 200
ALEXANDRIA,  VA  22314
Applicant Contact MARIE MARLOW
Correspondent
MDPO, LLC
901 KING ST.
SUITE 200
ALEXANDRIA,  VA  22314
Correspondent Contact MARIE MARLOW
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received12/07/2009
Decision Date 08/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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