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510(k) K241424

InnoCare Specialty Foley Catheter by Innocare Urologics, LLC — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2024
Date Received
May 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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