• 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 tray, catheterization, sterile urethral, with or without catheter (kit)
510(k) Number K002803
Device Name THE O'NEIL STERILE FIELD URINARY CATHETER KIT
Applicant
GO MEDICAL INDUSTRIES PTY. LTD.
200 CHURCHILL AVE.
SUBIACO, PERTH,  AU 6008
Applicant Contact GEORGE O'NEIL
Correspondent
GO MEDICAL INDUSTRIES PTY. LTD.
200 CHURCHILL AVE.
SUBIACO, PERTH,  AU 6008
Correspondent Contact GEORGE O'NEIL
Regulation Number876.5130
Classification Product Code
FCM  
Subsequent Product Code
KOD  
Date Received09/08/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-