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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number K191642
Device Name TK Sterile Piston Syringe without Needle
Applicant
Anhui Tiankang Medical Technology Co.,Ltd.
No.228 Weiyi Road, Economic Development Zone
Tianchang,  CN 239300
Applicant Contact Bai Baodong
Correspondent
Anhui Tiankang Medical Technology Co.,Ltd.
No.228 Weiyi Road, Economic Development Zone
Tianchang,  CN 239300
Correspondent Contact Bai Baodong
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/19/2019
Decision Date 01/06/2020
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
Recalls CDRH Recalls
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