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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, short-term less than 30 days
510(k) Number K060341
Device Name SHERLOCK TIP LOCATION SYSTEM (TLS)
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 Number880.5200
Classification Product Code
FOZ  
Date Received02/10/2006
Decision Date 04/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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