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FDA 510(k) Application Details - K133834
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
More FDA Info for this Device
510(K) Number
K133834
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
DEPUY (IRELAND)
LOUGHBEG RINGASKIDDY
CO. CORK IRELAND IE
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Contact
KELLIE MYERS
Other 510(k) Applications for this Contact
Regulation Number
888.3660
More FDA Info for this Regulation Number
Classification Product Code
KWS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/17/2013
Decision Date
04/03/2014
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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