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 K212544
Device Name MiniLoad Syringe
Applicant
Ocuject, LLC
1441 Avocado Ave.
Suite 204
Newport Beach,  CA  92660
Applicant Contact Rebecca K Pine
Correspondent
Ocuject, LLC
1441 Avocado Ave.
Suite 204
Newport Beach,  CA  92660
Correspondent Contact Rebecca K Pine
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/12/2021
Decision Date 10/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-