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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 K964688
Device Name LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
Applicant
CORDIS CORP.
P.O. BOX 4917
35 & 40 TECHNOLOGY DRIVE
WARREN,  NJ  07059
Applicant Contact JOAN MARTIN
Correspondent
CORDIS CORP.
P.O. BOX 4917
35 & 40 TECHNOLOGY DRIVE
WARREN,  NJ  07059
Correspondent Contact JOAN MARTIN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/22/1996
Decision Date 06/20/1997
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
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