Safety Blood Collection Sets For Single Use

Tubes, Vials, Systems, Serum Separators, Blood Collection

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

The following data is part of a premarket notification filed by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. with the FDA for Safety Blood Collection Sets For Single Use.

Pre-market Notification Details

Device IDK202188
510k NumberK202188
Device Name:Safety Blood Collection Sets For Single Use
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No. 2 Guanyin Road, Economic Development Zone Taihu, Anqing City,  CN 246400
ContactGang Yu
CorrespondentCharles Mack
IRC 2950 E Lindrick Drive Chandler,  AZ  85249
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-04
Decision Date2021-02-19

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