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FDA 510(k) Application Details - K142139
Device Classification Name
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510(K) Number
K142139
Device Name
SMR 40MM GLENOSPHERE
Applicant
LIMACORPORATE S.P.A.
5010 LODGE POLE LANE
FORT WAYNE, IN 46814 US
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Contact
STEPHEN PEOPLES
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Regulation Number
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Classification Product Code
PHX
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Date Received
08/05/2014
Decision Date
11/07/2014
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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