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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K893474
Device Name BARD CATH LAB THERMODILUTION CATHETER
Applicant
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Applicant Contact ROBERT KELLY
Correspondent
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Correspondent Contact ROBERT KELLY
Regulation Number870.1240
Classification Product Code
DYG  
Date Received05/04/1989
Decision Date 09/05/1989
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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