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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 K924250
FOIA Releasable 510(k) K924250
Device Name PLASTIC LOW PROFILE SUBCUTANEOUS PORT
Applicant
Bard Access Systems, Inc.
5425 W. Amelia Earnhart Dr.
Salt Lake City,  UT  84116
Applicant Contact JACK SPEER
Correspondent
Bard Access Systems, Inc.
5425 W. Amelia Earnhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact JACK SPEER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received08/24/1992
Decision Date 10/04/1993
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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