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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 K913524
Device Name SILICONE MALE EXTERNAL CATHETER
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact BYRON H WICKETT
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact BYRON H WICKETT
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received08/08/1991
Decision Date 10/04/1991
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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