The following data is part of a premarket notification filed by David Bull Laboratories, Usa, Inc. with the FDA for Rapi-ject(r) Syringe.
| Device ID | K911440 |
| 510k Number | K911440 |
| Device Name: | RAPI-JECT(R) SYRINGE |
| Classification | Syringe, Piston |
| Applicant | DAVID BULL LABORATORIES, USA, INC. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
| Contact | John Rohrbough |
| Correspondent | John Rohrbough DAVID BULL LABORATORIES, USA, INC. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-01 |
| Decision Date | 1991-12-30 |