FDA 510(k) Application Details - K111097

Device Classification Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

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510(K) Number K111097
Device Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant FX SOLUTIONS
1663 RUE DE MAJORNAS
VIRIAT 01440 FR
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Contact CHERYL HASTINGS
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Regulation Number 888.3690

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Classification Product Code HSD
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Date Received 04/20/2011
Decision Date 11/09/2011
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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