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FDA 510(k) Application Details - K972813
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K972813
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
HOWMEDICA CORP.
359 VETERANS BLVD.
RUTHERFORD, NJ 07070 US
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Contact
VIVIAN KELLY
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
07/29/1997
Decision Date
10/09/1997
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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