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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K874690
Device Name GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
Applicant
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Applicant Contact LYNN R BRECKENRIDGE
Correspondent
Mentor Corp.
600 Pine Ave.
Goleta,  CA  93117
Correspondent Contact LYNN R BRECKENRIDGE
Regulation Number876.1725
Classification Product Code
FFX  
Date Received11/16/1987
Decision Date 02/08/1988
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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