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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 K161183
Device Name Halo One Thin-Walled Guiding Sheath
Applicant
C.R. BARD, INC
MOYNE UPPER
ENNISCORTHY,  IE
Applicant Contact FIONA NI MHULLAIN
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/27/2016
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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