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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K912919
Device Name MENTOR INFUSION LINE
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 Number876.5130
Classification Product Code
KNY  
Date Received07/03/1991
Decision Date 12/13/1991
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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