The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8e, Dur 8.
| Device ID | K023358 |
| 510k Number | K023358 |
| Device Name: | USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Terrence Sullivan |
| Correspondent | Terrence Sullivan ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-07 |
| Decision Date | 2003-01-03 |
| Summary: | summary |