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FDA 510(k) Application Details - K170555
Device Classification Name
More FDA Info for this Device
510(K) Number
K170555
Device Name
U Deliver Bolink ENFit Enteral Feeding Sets
Applicant
U Deliver Medical, LLC
10150 City Walk Drive, Suite A
Woodbury, MN 55129 US
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Contact
Brian Johnson
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Regulation Number
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Classification Product Code
PIF
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More FDA Info for this Product Code
Date Received
02/24/2017
Decision Date
08/17/2017
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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