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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K142075
Device Name BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
Applicant
Xeridiem (Formerly Mri)
4700 S. Overland Dr.
Tucson,  AZ  85714
Applicant Contact JESUS VALENCIA
Correspondent
Xeridiem (Formerly Mri)
4700 S. Overland Dr.
Tucson,  AZ  85714
Correspondent Contact JESUS VALENCIA
Regulation Number876.5980
Classification Product Code
PIF  
Date Received07/31/2014
Decision Date 01/08/2015
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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