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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
510(k) Number K011055
Device Name THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
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 Received04/06/2001
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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