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FDA 510(k) Application Details - K111061
Device Classification Name
More FDA Info for this Device
510(K) Number
K111061
Device Name
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
Applicant
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
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Contact
TEFFANY HUTTO
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/18/2011
Decision Date
07/20/2011
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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