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FDA 510(k) Application Details - K013772
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
More FDA Info for this Device
510(K) Number
K013772
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant
HOWMEDICA OSTEONICS
59 ROUTE 17
ALLENDALE, NJ 07401-1677 US
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Contact
KAREN ARIEMMA
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Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
LXT
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More FDA Info for this Product Code
Date Received
11/13/2001
Decision Date
12/03/2001
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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