The following data is part of a premarket notification filed by Duckworth & Kent, Ltd. with the FDA for Duckworth & Kent Ltd Injector, Model: Dk7797-2.
| Device ID | K072985 |
| 510k Number | K072985 |
| Device Name: | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 |
| Classification | Lens, Guide, Intraocular |
| 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 | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-23 |
| Decision Date | 2008-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055313818922 | K072985 | 000 |
| 05055313817222 | K072985 | 000 |