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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K041243
Device Name DOVER RED RUBBER ROBINSON CATHETER
Applicant
Tyco Healthcare
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact WEI ZHAO
Correspondent
Tyco Healthcare
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact WEI ZHAO
Regulation Number876.5130
Classification Product Code
KOD  
Date Received05/11/2004
Decision Date 07/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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