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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K982740
Device Name CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S
Applicant
Cordis Webster, Inc.
4750 Littlejohn St.
Baldwin Park,  CA  91706
Applicant Contact MARY ADAMS
Correspondent
Cordis Webster, Inc.
4750 Littlejohn St.
Baldwin Park,  CA  91706
Correspondent Contact MARY ADAMS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/06/1998
Decision Date 08/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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