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, Fluid, Non-Electrically Powered
510(k) Number K024018
Device Name AVANT GUARDIAN 101
Applicant
Avant Medical Corporation
3914 Kendall St.
San Diego,  CA  92109
Applicant Contact JOHN B SLATE
Correspondent
Avant Medical Corporation
3914 Kendall St.
San Diego,  CA  92109
Correspondent Contact JOHN B SLATE
Regulation Number880.5430
Classification Product Code
KZE  
Date Received12/04/2002
Decision Date 01/17/2003
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
-
-