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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 K013704
Device Name MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
Applicant
Mediplus, Ltd.
541 Moreno Circle NE
St. Petersburg,  FL  33703
Applicant Contact ELIZABETH M PAUL
Correspondent
Mediplus, Ltd.
541 Moreno Circle NE
St. Petersburg,  FL  33703
Correspondent Contact ELIZABETH M PAUL
Regulation Number876.1725
Classification Product Code
KLA  
Date Received11/08/2001
Decision Date 08/05/2002
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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