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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name port & catheter, implanted, subcutaneous, intravascular
510(k) Number K964066
Device Name DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
Original Applicant
bard access systems
5425 w. amelia earhart drive
salt lake city,  UT  84116
Original Contact peggy keiffer
Regulation Number880.5965
Classification Product Code
Date Received10/10/1996
Decision Date 03/06/1997
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