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 K221068
Device Name Sterile Hypodermic Syringes for Single Use with Needles
Applicant
Sichuan Prius Biotechnology Co., Ltd.
No.2 Prius Road, Luo Long Industrial Park Nanxi District
Yibin,  CN 644104
Applicant Contact Yan Liu
Correspondent
Mid-Link Consulting Co., Ltd
P.O.BOX 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received04/12/2022
Decision Date 10/04/2022
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
-
-