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 Catheter, Conduction, Anesthetic
510(k) Number K051401
Device Name ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
Applicant
I-Flow Corp.
20202 Windrow Dr.
Lake Forest,  CA  92630
Applicant Contact SHANE NOEHRE
Correspondent
I-Flow Corp.
20202 Windrow Dr.
Lake Forest,  CA  92630
Correspondent Contact SHANE NOEHRE
Regulation Number868.5120
Classification Product Code
BSO  
Date Received05/31/2005
Decision Date 11/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-