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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 K981909
Device Name BAXTER HEMOSTASIS VALVE INTRODUCERS
Applicant
BAXTER EDWARDS
17221 RED HILL AVE.
IRVINE,  CA  92614 -5627
Applicant Contact SCOTT BEGGINS
Correspondent
BAXTER EDWARDS
17221 RED HILL AVE.
IRVINE,  CA  92614 -5627
Correspondent Contact SCOTT BEGGINS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/01/1998
Decision Date 11/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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