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FDA 510(k) Application Details - K112069
Device Classification Name
More FDA Info for this Device
510(K) Number
K112069
Device Name
RSP GLENOID BASEPLATE POROUS COATED
Applicant
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
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Contact
WILLIAM GARZON
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Regulation Number
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Classification Product Code
PHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/20/2011
Decision Date
11/15/2011
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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