The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Deseret (r) T-port (r) Multi Flo(tm) And Deseret (r)prn Adapter.
Device ID | K950304 |
510k Number | K950304 |
Device Name: | DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER |
Classification | Set, Administration, Intravascular |
Applicant | BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | C. J Welle |
Correspondent | C. J Welle BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-25 |
Decision Date | 1995-03-14 |