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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 K160795
Device Name United Urologics Intermittent Catheter
Applicant
ROBLING MEDICAL
90 WEATHERS STREET
YOUNGSVILLE,  NC  27596
Applicant Contact Diane Peper
Correspondent
ROBLING MEDICAL
90 WEATHERS STREET
YOUNGSVILLE,  NC  27596
Correspondent Contact Diane Peper
Regulation Number876.5130
Classification Product Code
GBM  
Date Received03/23/2016
Decision Date 06/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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