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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 K063240
Device Name SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR
Applicant
C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY,  UT  84116
Applicant Contact LYNN M KIRCHOFF
Correspondent
C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact LYNN M KIRCHOFF
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/26/2006
Decision Date 11/21/2006
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
Recalls CDRH Recalls
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