The following data is part of a premarket notification filed by Duckworth & Kent, Ltd. with the FDA for Duckworth & Kent Ltd Cartridge Lens Delivery System, Model Dk7797.
| Device ID | K053176 |
| 510k Number | K053176 |
| Device Name: | DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | DUCKWORTH & KENT, LTD. 7 MARQUIS BUSINESS CENTRE ROYSTON RD. Baldock, Hertsfordshire, GB Sg7 6xl |
| Contact | Martin Lock |
| Correspondent | Martin Lock DUCKWORTH & KENT, LTD. 7 MARQUIS BUSINESS CENTRE ROYSTON RD. Baldock, Hertsfordshire, GB Sg7 6xl |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2006-01-30 |