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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 K911581
Device Name PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION
Applicant
Johnson & Johnson Interventional Systems
150 Mt. Bethel Rd.
P.O. Box 4917
Warren,  NJ  07059
Applicant Contact JAMES P O'DONNELL
Correspondent
Johnson & Johnson Interventional Systems
150 Mt. Bethel Rd.
P.O. Box 4917
Warren,  NJ  07059
Correspondent Contact JAMES P O'DONNELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/09/1991
Decision Date 06/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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