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 Rongeur, Manual
510(k) Number K080494
Device Name BAXANO ULTRA LOW PROFILE RONGEUR
Applicant
Baxano, Inc.
5582 Chalon Rd.
Yorba Linda,  CA  92886
Applicant Contact SHARON ROCKWELL
Correspondent
Baxano, Inc.
5582 Chalon Rd.
Yorba Linda,  CA  92886
Correspondent Contact SHARON ROCKWELL
Regulation Number882.4840
Classification Product Code
HAE  
Date Received02/22/2008
Decision Date 03/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-