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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 K190310
Device Name U Deliver Bolink ENFit Enteral Feeding Sets
Applicant
U Deliver Medical, LLC
7900 Excelsior Blvd. Suite 108
Hopkins,  MN  55343
Applicant Contact Brian Johnson
Correspondent
Vista Regulatory Solutions, LLC
18205 E. Sioux Vista Dr.
Jordan,  MN  55352
Correspondent Contact Thomas Dold
Regulation Number876.5980
Classification Product Code
PIF  
Date Received02/12/2019
Decision Date 05/31/2019
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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