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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 K010420
Device Name RUSCH MMG/O'NEIL CATHETER
Applicant
RUSCH, INC.
2450 MEADOWBROOK PKWY.
DULUTH,  GA  30096
Applicant Contact WILLIAM SLEVIN
Correspondent
RUSCH, INC.
2450 MEADOWBROOK PKWY.
DULUTH,  GA  30096
Correspondent Contact WILLIAM SLEVIN
Regulation Number876.5130
Classification Product Code
FCM  
Subsequent Product Code
KOD  
Date Received02/12/2001
Decision Date 05/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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