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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K043193
Device Name BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
Applicant
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30014
Applicant Contact FRANCES E HARRISON
Correspondent
C.R. BARD, INC.
8195 INDUSTRIAL BLVD
COVINGTON,  GA  30014
Correspondent Contact FRANCES E HARRISON
Regulation Number876.4620
Classification Product Code
FAD  
Date Received11/18/2004
Decision Date 12/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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