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FDA 510(k) Application Details - K222705
Device Classification Name
Catheter, Nephrostomy
More FDA Info for this Device
510(K) Number
K222705
Device Name
Catheter, Nephrostomy
Applicant
YouCare Technology Co., Ltd. (Wuhan)
Great Wall Science and Technology Park
East Lake Development Zone, Wuhan
Wuhan CN
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Contact
Bing Hu
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LJE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/07/2022
Decision Date
05/22/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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