FDA 510(k) Application Details - K110598

Device Classification Name

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510(K) Number K110598
Device Name SMR REVERSE SHOULDER SYSTEM
Applicant LIMACORPORATE S.P.A.
P.O. BOX 696
WINONA LAKE, IN 46590-696 US
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Contact CHERYL HASTINGS
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Regulation Number

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Classification Product Code PHX
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Date Received 03/02/2011
Decision Date 08/18/2011
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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