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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urological (antimicrobial) and accessories
510(k) Number K033477
Device Name HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
Applicant
ROCHESTER MEDICAL CORP.
ONE ROCHESTER MEDICAL DR.
STEWARTVILLE,  MN  55976
Applicant Contact ROB ANGLIN
Correspondent
ROCHESTER MEDICAL CORP.
ONE ROCHESTER MEDICAL DR.
STEWARTVILLE,  MN  55976
Correspondent Contact ROB ANGLIN
Regulation Number876.5130
Classification Product Code
MJC  
Date Received11/03/2003
Decision Date 06/10/2004
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 Yes
Recalls CDRH Recalls
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