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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, Long-Term Greater Than 30 Days
510(k) Number K935380
Device Name VASCULAR ACCESS CATHETER ACCESSORIES
Applicant
Bard Access Systems, Inc.
5425 W. Amelia Earnhart Dr.
Salt Lake City,  UT  84116
Applicant Contact JANE A MARTIN
Correspondent
Bard Access Systems, Inc.
5425 W. Amelia Earnhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact JANE A MARTIN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received11/08/1993
Decision Date 02/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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