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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
510(k) Number K000723
Device Name HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
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
KOD  
Date Received03/06/2000
Decision Date 05/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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