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510(k) K192533

Health Line CT CVC by Health Line International Corporation — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2019
Date Received
September 16, 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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