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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 K031617
Device Name MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
Applicant
Mediplus , Ltd.
9109 Copenhaver Dr.
Potomac,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
Mediplus , Ltd.
9109 Copenhaver Dr.
Potomac,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Regulation Number876.1725
Classification Product Code
KLA  
Date Received05/23/2003
Decision Date 01/16/2004
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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