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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 K001139
Device Name PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
Applicant
Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Applicant Contact MARY ADAMS
Correspondent
Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Correspondent Contact MARY ADAMS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/10/2000
Decision Date 05/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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