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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fab, Rhodamine, Antigen, Antiserum, Control
510(k) Number K013304
Device Name BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
Applicant
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact LESLIE WOOD
Correspondent
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact LESLIE WOOD
Regulation Number866.5520
Classification Product Code
DBY  
Date Received10/04/2001
Decision Date 01/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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