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FDA 510(k) Application Details - K071948
Device Classification Name
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510(K) Number
K071948
Device Name
AEQUALIS REVERSED ADAPTER
Applicant
TORNIER
161 RUE LAVOISIER
MONTBONNOT
SAINT-ISMIER CEDEX 38334 FR
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Contact
Mireille Lemery
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Regulation Number
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Classification Product Code
PHX
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Date Received
07/13/2007
Decision Date
10/18/2007
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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