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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 K151985
Device Name PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
Applicant
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Bryan Stone
Correspondent
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact Bryan Stone
Regulation Number880.5970
Classification Product Code
LJS  
Date Received07/17/2015
Decision Date 06/14/2016
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
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