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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K000793
Device Name 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
Applicant
GUIDANT CORP.
26531 YNEZ RD.
TEMECULA,  CA  92591 -4630
Applicant Contact BYRON LAMBERT
Correspondent
GUIDANT CORP.
26531 YNEZ RD.
TEMECULA,  CA  92591 -4630
Correspondent Contact BYRON LAMBERT
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
LIT  
Date Received03/13/2000
Decision Date 04/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
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