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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 K945628
Device Name CLEAR ADVANTAGE II
Applicant
MENTOR CORP.
5425 HOLLISTER AVE.
SANTA BARBARA,  CA  93111
Applicant Contact BYRON H WICKET
Correspondent
MENTOR CORP.
5425 HOLLISTER AVE.
SANTA BARBARA,  CA  93111
Correspondent Contact BYRON H WICKET
Regulation Number876.5250
Classification Product Code
EXJ  
Date Received11/16/1994
Decision Date 07/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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