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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 K232046
Device Name Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
Applicant
Xeridiem Medical Devices, A Spectrum Plastics Group Company
4700 S. Overland Dr.
Tucson,  AZ  85714
Applicant Contact Steve Murray
Correspondent
Xeridiem Medical Devices, A Spectrum Plastics Group Company
4700 S. Overland Dr.
Tucson,  AZ  85714
Correspondent Contact Steve Murray
Regulation Number876.5980
Classification Product Code
PIF  
Date Received07/10/2023
Decision Date 10/06/2023
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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