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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K010801
Device Name T2 FEMORAL NAIL
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Applicant Contact KAREN ARIEMMA
Correspondent
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/16/2001
Decision Date 04/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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