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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name midline catheter
510(k) Number K162900
Device Name PowerMidline Catheter
Applicant
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Casey Coombs
Correspondent
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Casey Coombs
Regulation Number880.5200
Classification Product Code
PND  
Date Received10/17/2016
Decision Date 12/14/2016
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
Recalls CDRH Recalls
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