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 Saline, Vascular Access Flush
510(k) Number K231363
Device Name Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
Applicant
Hantech Medical Device Co., Ltd.
No 288 Sanheng Rd., Changhe Industrial Park, Cixi
Ningbo,  CN 315326
Applicant Contact Arnold Yang
Correspondent
Hantech Medical Device Co., Ltd.
No 288 Sanheng Rd., Changhe Industrial Park, Cixi
Ningbo,  CN 315326
Correspondent Contact Arnold Yang
Regulation Number880.5200
Classification Product Code
NGT  
Date Received05/11/2023
Decision Date 09/27/2023
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
Predetermined Change
Control Plan Authorized		 No
-
-