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FDA 510(k) Application Details - K150579
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K150579
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
CARDINAL HEALTH
1500 Waukegan Rd
Waukegan, IL 60085 US
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Contact
TATYANA BOGDAN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2015
Decision Date
04/29/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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