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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 K170158
Device Name PowerGlide ST Midline Catheter
Applicant
C. R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact JACOB LEE
Correspondent
C. R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact JACOB LEE
Regulation Number880.5200
Classification Product Code
PND  
Date Received01/18/2017
Decision Date 06/01/2017
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
Recalls CDRH Recalls
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