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FDA 510(k) Application Details - K190310
Device Classification Name
More FDA Info for this Device
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 US
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Contact
Brian Johnson
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/2019
Decision Date
05/31/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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