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510(k) K252537

Rusch SoftSimplastic Foley Catheters by Teleflex Medical Sdn. Bhd. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2026
Date Received
August 12, 2025
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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