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510(k) K180530

Imager II Urology Torque Catheter by Boston Scientific Corporation — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2018
Date Received
February 28, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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