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510(k) K183036

Dilator Sets by Cook Incorporated — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2018
Date Received
November 1, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

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