The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Acmi Dur-hl Laser Systems.
| Device ID | K060752 |
| 510k Number | K060752 |
| Device Name: | ACMI DUR-HL LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Lorraine Calzetta |
| Correspondent | Lorraine Calzetta ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-05-25 |
| Summary: | summary |