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FDA 510(k) Application Details - K060545
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K060545
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
TORNIER
RUE DOYEN GOSSE
ST. ISMIER 38330 FR
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Contact
Mireille Lemery
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Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
03/01/2006
Decision Date
04/21/2006
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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