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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Esophageal Motility, Anorectal Motility, And Tube
510(k) Number K032138
Device Name MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
Applicant
Medtronic Vascular
4000 Lexington Ave., N.
Shoreview,  MN  55126 -2893
Applicant Contact DEBORAH KIDDER
Correspondent
Medtronic Vascular
4000 Lexington Ave., N.
Shoreview,  MN  55126 -2893
Correspondent Contact DEBORAH KIDDER
Regulation Number876.1725
Classification Product Code
KLA  
Date Received07/11/2003
Decision Date 10/09/2003
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
Predetermined Change
Control Plan Authorized		 No
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