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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 K955785
Device Name TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
Applicant
C.R. Bard, Inc.
12 Elizabeth Dr.
Chelmsford,  MA  01824
Applicant Contact ROBERT T MIRAGILUOLO
Correspondent
C.R. Bard, Inc.
12 Elizabeth Dr.
Chelmsford,  MA  01824
Correspondent Contact ROBERT T MIRAGILUOLO
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/21/1995
Decision Date 03/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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