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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K102405
Device Name INFUSION SET FOR POWERPICC SOLO 2 CATHETER
Applicant
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Applicant Contact LYNN M KIRCHOFF
Correspondent
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Correspondent Contact LYNN M KIRCHOFF
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/24/2010
Decision Date 07/21/2011
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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