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510(k) K202188

Safety Blood Collection Sets for Single Use by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2021
Date Received
August 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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