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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K981612
Device Name ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY 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
EZL  
Date Received05/06/1998
Decision Date 07/08/1998
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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