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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, Short-Term Less Than 30 Days
510(k) Number K191232
Device Name AccuCath Ace Intravascular Catheter
Applicant
C.R. Bard, Inc
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Mona Shahrebani
Correspondent
C.R. Bard, Inc
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Mona Shahrebani
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/08/2019
Decision Date 09/18/2019
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
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