The following data is part of a premarket notification filed by David Bull Laboratories, Usa, Inc. with the FDA for Onco-vial Adapter.
| Device ID | K926071 |
| 510k Number | K926071 |
| Device Name: | ONCO-VIAL ADAPTER |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | DAVID BULL LABORATORIES, USA, INC. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
| Contact | John Rohrbourgh |
| Correspondent | John Rohrbourgh DAVID BULL LABORATORIES, USA, INC. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1994-02-14 |