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510(k) K110794

AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS by Ameco Medical Industries — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2011
Date Received
March 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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