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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K905720
Device Name PALMAZ BILIARY STENT
Applicant
Johnson & Johnson Interventional Systems
35 Technology Dr.
P.O. Box 4917
Warren,  NJ  07060
Applicant Contact RAYMOND E URSICK
Correspondent
Johnson & Johnson Interventional Systems
35 Technology Dr.
P.O. Box 4917
Warren,  NJ  07060
Correspondent Contact RAYMOND E URSICK
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/21/1990
Decision Date 02/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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