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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K100366
Device Name MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY
Applicant
Maxter Catheters
Village D'Entreprises Saint Henri Ii, Rue Anne Gacon
Marseille,  FR 13016
Applicant Contact M. BERNARD DAURELLE
Correspondent
Maxter Catheters
Village D'Entreprises Saint Henri Ii, Rue Anne Gacon
Marseille,  FR 13016
Correspondent Contact M. BERNARD DAURELLE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/12/2010
Decision Date 06/14/2010
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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