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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 K001143
Device Name RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
Applicant
ROCHESTER MEDICAL CORP.
ONE ROCHESTER MEDICAL DR.
STEWARTVILLE,  MN  55976
Applicant Contact MARY WILEN
Correspondent
ROCHESTER MEDICAL CORP.
ONE ROCHESTER MEDICAL DR.
STEWARTVILLE,  MN  55976
Correspondent Contact MARY WILEN
Regulation Number876.5130
Classification Product Code
MJC  
Date Received04/10/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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