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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K003784
Device Name MENTOR SELF-CATH PLUS
Applicant
MENTOR CORP.
201 MENTOR DR.
SANTA BARBARA,  CA  93111
Applicant Contact DONNA A CRAWFORD
Correspondent
MENTOR CORP.
201 MENTOR DR.
SANTA BARBARA,  CA  93111
Correspondent Contact DONNA A CRAWFORD
Regulation Number876.5130
Classification Product Code
EZL  
Date Received12/07/2000
Decision Date 03/05/2001
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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