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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 K153440
Device Name PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
Applicant
C.R BARD, INC.
605 NORTH 5600 WEST
Salt Lake City,  UT  84116
Applicant Contact Darlene Hull
Correspondent
C.R BARD, INC.
605 NORTH 5600 WEST
Salt Lake City,  UT  84116
Correspondent Contact Darlene Hull
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/27/2015
Decision Date 08/18/2016
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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