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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K212019
Device Name Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
Applicant
Jiangsu Micsafe Medical Technology Co., Ltd
Xituan Industrial Park, Dafeng District
Yancheng,  CN 224125
Applicant Contact Tony Yang
Correspondent
Jiangsu Micsafe Medical Technology Co., Ltd
Xituan Industrial Park, Dafeng District
Yancheng,  CN 224125
Correspondent Contact Tony Yang
Regulation Number862.1675
Classification Product Code
JKA  
Date Received06/28/2021
Decision Date 11/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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