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510(k) K180028

Cook 810 Set, Desilets-Hoffman Introducer Set by Cook Incorporated — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2018
Date Received
January 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter, Ureteral
Device Class
Class II
Regulation Number
876.5470
Review Panel
GU
Submission Type

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