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FDA 510(k) Application Details - K201697
Device Classification Name
Catheter, Umbilical Artery
More FDA Info for this Device
510(K) Number
K201697
Device Name
Catheter, Umbilical Artery
Applicant
Haolang Medical USA Corporation
1100 Bellevue Way NE 8A-533
Bellevue, WA 98004 US
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Contact
Lisa Xu
Other 510(k) Applications for this Contact
Regulation Number
880.5200
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Classification Product Code
FOS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2020
Decision Date
05/06/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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