Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name set, administration, intravascular
510(k) Number K191640
Device Name TK Intravascular Administration Set
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 Number880.5440
Classification Product Code
FPA  
Date Received06/19/2019
Decision Date 08/26/2020
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
-
-