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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urethral
510(k) Number K192577
Device Name Actreen Hi-Lite Intermittent Urinary Catheters
Applicant
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown,  PA  18109
Applicant Contact Anita J. Nemeth
Correspondent
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown,  PA  18109
Correspondent Contact Anita J. Nemeth
Regulation Number876.5130
Classification Product Code
GBM  
Date Received09/19/2019
Decision Date 05/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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