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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 K970704
Device Name PERSONAL CATHETER
Applicant
Rochester Medical Corp.
1500 NW 2nd Ave.
P.O. Box 188
Stewartville,  MN  55976
Applicant Contact MARY WILEN
Correspondent
Rochester Medical Corp.
1500 NW 2nd Ave.
P.O. Box 188
Stewartville,  MN  55976
Correspondent Contact MARY WILEN
Regulation Number876.5130
Classification Product Code
GBM  
Date Received02/26/1997
Decision Date 03/13/1997
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
Predetermined Change
Control Plan Authorized		 No
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