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FDA 510(k) Application Details - K053472
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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510(K) Number
K053472
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH, NJ 07430 US
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Contact
VIVIAN KELLY
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Regulation Number
888.3030
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Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
12/14/2005
Decision Date
01/11/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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