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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 K222678
Device Name Mobility+ Enteral Feeding System
Applicant
Rockfield Medical
Ihub Gmit, Dublin Rd.
Galway,  IE H91 DCH9
Applicant Contact Orla Connaughton
Correspondent
Rockfield Medical
Ihub Gmit, Dublin Rd.
Galway,  IE H91 DCH9
Correspondent Contact Orla Connaughton
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
KNT  
Date Received09/06/2022
Decision Date 10/27/2022
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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