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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K950303
Device Name DESERET(R) I.V. LOOP AND DESERET (R) J LOOP
Applicant
Becton Dickinson Vascular Access, Inc.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact C. J WELLE
Correspondent
Becton Dickinson Vascular Access, Inc.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact C. J WELLE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/25/1995
Decision Date 03/14/1995
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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