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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 K150579
Device Name Cardinal Health External Fixation System
Applicant
CARDINAL HEALTH
1500 Waukegan Rd
Waukegan,  IL  60085
Applicant Contact TATYANA BOGDAN
Correspondent
CARDINAL HEALTH
1500 Waukegan Rd
Waukegan,  IL  60085
Correspondent Contact TATYANA BOGDAN
Regulation Number888.3030
Classification Product Code
KTT  
Date Received03/09/2015
Decision Date 04/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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