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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
Recalls CDRH Recalls
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