FDA 510(k) Application Details - K112069

Device Classification Name

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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
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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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