FDA 510(k) Application Details - K041873

Device Classification Name

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510(K) Number K041873
Device Name AEQUALIS REVERSED SHOULDER PROSTHESIS
Applicant TORNIER
ZIRST-161, RUE LAVOISIER
MONTBONNOT 38330 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 07/12/2004
Decision Date 08/25/2004
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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