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 Injector And Syringe, Angiographic
510(k) Number K241109
Device Name Single-use Sterile High-pressure Angiographic Syringes and Accessories
Applicant
Shenzhen Boon Medical Supply Co., Ltd.
No.18 Jirong Road, Shenkeng, Henggang Street
Longgang District
Shenzhen,  CN 518173
Applicant Contact Shengyu Fan
Correspondent
Shenzhen Boon Medical Supply Co., Ltd.
No.18 Jirong Road, Shenkeng, Henggang Street
Longgang District
Shenzhen,  CN 518173
Correspondent Contact Shengyu Fan
Regulation Number870.1650
Classification Product Code
DXT  
Date Received04/22/2024
Decision Date 08/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-