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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K140345
FOIA Releasable 510(k) K140345
Device Name THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
Applicant
C.R Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact JAMES R DAVIS
Correspondent
C.R Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact JAMES R DAVIS
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/11/2014
Decision Date 03/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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