The following data is part of a premarket notification filed by Ellis Pharmaceutical Consulting, Inc. with the FDA for Empty I.v. Container.
| Device ID | K910936 |
| 510k Number | K910936 |
| Device Name: | EMPTY I.V. CONTAINER |
| Classification | Container, I.v. |
| 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 | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-07-16 |