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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Incontinence, Urosheath Type, Sterile
510(k) Number K923136
Device Name MALE EXTERNAL CATHETER
Applicant
Rochester Medical Corp.
1500 NW 2nd Ave.
P.O. Box 188
Stewartville,  MN  55976
Applicant Contact RICHARD D FRYAR
Correspondent
Rochester Medical Corp.
1500 NW 2nd Ave.
P.O. Box 188
Stewartville,  MN  55976
Correspondent Contact RICHARD D FRYAR
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received06/29/1992
Decision Date 12/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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