The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Acmi Dur-digital Ureteroscope And Choledochoscope System.
| Device ID | K060269 |
| 510k Number | K060269 |
| Device Name: | ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM |
| Classification | Choledochoscope 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 | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-01 |
| Decision Date | 2006-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925029170 | K060269 | 000 |
| 00821925011113 | K060269 | 000 |
| 00821925008151 | K060269 | 000 |
| 00821925008144 | K060269 | 000 |