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FDA 510(k) Application Details - K021026
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K021026
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE, NJ 07401-1677 US
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Contact
KAREN ARIEMMA
Other 510(k) Applications for this Contact
Regulation Number
888.3020
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Classification Product Code
HSB
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More FDA Info for this Product Code
Date Received
03/29/2002
Decision Date
04/25/2002
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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