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 K082138
Device Name AIRGENT, MODEL AG7000010
Applicant
Perfaction, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Perfaction, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number880.5430
Classification Product Code
KZE  
Date Received07/29/2008
Decision Date 01/23/2009
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
-
-