The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Deseret(r) I.v. Loop And Deseret (r) J Loop.
Device ID | K950303 |
510k Number | K950303 |
Device Name: | DESERET(R) I.V. LOOP AND DESERET (R) J LOOP |
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903851213 | K950303 | 000 |
50382903851206 | K950303 | 000 |