THE O’NEIL STERILE FIELD URINARY CATHETER KIT


definition

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
Original Applicant
GO MEDICAL INDUSTRIES PTY. LTD.
200 churchill ave.
subiaco, perth, 

AU

6008

Original Contact george o’neil
Regulation Number 876.5130
Classification Product Code
FCM  
Subsequent Product Code
KOD  
Date Received 09/08/2000
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