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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 K926139
Device Name CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH
Original Applicant
BARD ACCESS SYSTEMS, INC.
5425 west amelia earnhart dr.
salt lake city,  UT  84116
Original Contact jane ann martin
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/07/1992
Decision Date 01/03/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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