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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 K180548
Device Name 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
Applicant
C.R. Bard, Inc (Bard Has Joined Bd)
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Bryan Stone
Correspondent
C.R. Bard, Inc (Bard Has Joined Bd)
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact Bryan Stone
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/01/2018
Decision Date 04/26/2018
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
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