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 Syringe, Piston
510(k) Number K222672
Device Name Disposable Insulin Syringe
Applicant
Hantech Medical Device Co., Ltd.
No 288, Sanheng Rd. Changhe Industridal Park, Cixi
Ningbo,  CN 315326
Applicant Contact Rachel Jin
Correspondent
Hantech Medical Device Co., Ltd.
No 288, Sanheng Rd. Changhe Industridal Park, Cixi
Ningbo,  CN 315326
Correspondent Contact Rachel Jin
Regulation Number880.5860
Classification Product Code
FMF  
Date Received09/06/2022
Decision Date 03/06/2023
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
-
-