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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K192681
Device Name Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
Applicant
Jiangsu Kangbao Medical Equipment Co., Ltd.
78#, North Suzhong Road Baoying
Yangzhou,  CN 225800
Applicant Contact Rujun Tang
Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
JKA  
Date Received09/26/2019
Decision Date 07/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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