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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K050008
Device Name MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
Applicant
MENTOR CORP.
201 MENTOR DRIVE
SANTA BARBARA,  CA  93111
Applicant Contact DONNA A CRAWFORD
Correspondent
MENTOR CORP.
201 MENTOR DRIVE
SANTA BARBARA,  CA  93111
Correspondent Contact DONNA A CRAWFORD
Regulation Number876.5130
Classification Product Code
EZD  
Subsequent Product Code
FCM  
Date Received01/03/2005
Decision Date 06/03/2005
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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