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510(k) K193158

ACENT™ Central Venous Catheter by Global Medikit Limited — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2020
Date Received
November 14, 2019
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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