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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 K991389
Device Name ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
TONSBAKKEN 16-18
SKOVLUNDE
COPENHAGEN,  DK DK-2740
Applicant Contact ANN-CHRISTINE JONSSON
Correspondent
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
TONSBAKKEN 16-18
SKOVLUNDE
COPENHAGEN,  DK DK-2740
Correspondent Contact ANN-CHRISTINE JONSSON
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/21/1999
Decision Date 07/15/1999
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
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