FDA 510(k) Application Details - K060209

Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

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510(K) Number K060209
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant TORNIER
161 RUE LAVOISIER
MONTBONNOT
SAINT-ISMIER CEDEX 38334 FR
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Contact Mireille Lemery
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Regulation Number 888.3660

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Classification Product Code KWS
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Date Received 01/27/2006
Decision Date 03/02/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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