The following data is part of a premarket notification filed by Ellis Pharmaceutical Consulting, Inc. with the FDA for The Mcp-70-se System.
| Device ID | K844180 |
| 510k Number | K844180 |
| Device Name: | THE MCP-70-SE SYSTEM |
| Classification | Device, Beam Limiting, X-ray, Therapeutic |
| 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 | KQA |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-26 |
| Decision Date | 1985-02-01 |