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510(k) K203670

Extra Large Check-Flo Introducer by Cook Incorporated — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2021
Date Received
December 16, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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