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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K254111
Device Name Irrigation/Urology Sets
Applicant
B.Braun Medical, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Rachel Pappas
Correspondent
B.Braun Medical, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Rachel Pappas
Regulation Number876.5130
Classification Product Code
LJH  
Date Received12/19/2025
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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