The following data is part of a premarket notification filed by Ellis Pharmaceutical Consulting, Inc. with the FDA for Quadroject(tm).
| Device ID | K884233 |
| 510k Number | K884233 |
| Device Name: | QUADROJECT(TM) |
| Classification | Syringe, Piston |
| Applicant | ELLIS PHARMACEUTICAL CONSULTING, INC. 913 STATE RD. Princeton, NJ 08540 -1484 |
| Contact | Levi Ellis |
| Correspondent | Levi Ellis ELLIS PHARMACEUTICAL CONSULTING, INC. 913 STATE RD. Princeton, NJ 08540 -1484 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-07 |
| Decision Date | 1989-01-30 |