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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 K150769
Device Name Cardinal Health Trochanteric IM Nail System
Applicant
Cardinalhealth
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact Tatyana Bogdan
Correspondent
Cardinalhealth
720 S. Colorado Blvd., Suite 550s
Denver,  CO  80246
Correspondent Contact Kyungyoon Kang
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/24/2015
Decision Date 12/14/2015
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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