The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Dual Lumen Catheter.
| Device ID | K043581 |
| 510k Number | K043581 |
| Device Name: | DUAL LUMEN CATHETER |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham Baillie |
| Correspondent | Graham Baillie ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-28 |
| Decision Date | 2005-03-03 |
| Summary: | summary |