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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 K093089
Device Name MAGNUM NAIL
Applicant
Robert Reid, Inc.
8202 Sherman Rd.
Chesterland,  OH  44026 -2141
Applicant Contact KAREN WARDEN
Correspondent
Robert Reid, Inc.
8202 Sherman Rd.
Chesterland,  OH  44026 -2141
Correspondent Contact KAREN WARDEN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/01/2009
Decision Date 11/13/2009
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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