The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Acmi Autoclavable Ureteroscope, Models Mr-6a And Mr-6al.
| Device ID | K052044 |
| 510k Number | K052044 |
| Device Name: | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Terrence E Sullivan |
| Correspondent | Terrence E Sullivan ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-28 |
| Decision Date | 2005-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925007826 | K052044 | 000 |
| 00821925006232 | K052044 | 000 |
| 00821925006225 | K052044 | 000 |