Home / 510(k) Clearances / K214075

510(k) K214075

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2022
Date Received
December 27, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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