The following data is part of a premarket notification filed by Duckworth & Kent, Ltd. with the FDA for Capsule Tension Ring Inserter, Model 7-810.
| Device ID | K042478 |
| 510k Number | K042478 |
| Device Name: | CAPSULE TENSION RING INSERTER, MODEL 7-810 |
| Classification | Injector, Capsular Tension Ring |
| 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 | NCE |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-13 |
| Decision Date | 2004-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055313811398 | K042478 | 000 |