The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Acmi M4 Telescopes.
| Device ID | K031758 |
| 510k Number | K031758 |
| Device Name: | ACMI M4 TELESCOPES |
| Classification | Telescope, Rigid, Endoscopic |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 -2104 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 -2104 |
| Product Code | FBP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-06 |
| Decision Date | 2003-09-02 |
| Summary: | summary |