FDA 510(k) Application Details - K172021

Device Classification Name

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510(K) Number K172021
Device Name LigaPASS
Applicant Medicrea International S.A.
5389 route de Strasbourg - Vancia
Rillieux-La-Pape 69140 FR
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Contact David Ryan
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Regulation Number

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Classification Product Code OWI
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Date Received 07/05/2017
Decision Date 08/30/2017
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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