FDA 510(k) Application Details - K143256

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

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510(K) Number K143256
Device Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant Limacorporate S.P.A.
Via Nazionale, 52
Villanova di San Daniele 33038 IT
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Contact Stephen J. Peoples
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Regulation Number 888.3660

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Classification Product Code KWS
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Date Received 11/13/2014
Decision Date 05/28/2015
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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