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510(k) K182252

Cook Unimpregnated Central Venous Catheter by Cook Incorporated — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2019
Date Received
August 20, 2018
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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