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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 K791963
FOIA Releasable 510(k) K791963
Device Name USCI MULLINS TRANSSEPTAL CATHETER INTRO.
Applicant
C.R. Bard, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
C.R. Bard, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/01/1979
Decision Date 11/13/1979
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
Recalls CDRH Recalls
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