CAPSULE TENSION RING INSERTER, MODEL 7-810
FDA 510(k) clearance K042478 · decided 2004-12-28
Clearance details
- K-number
- K042478
- Device name
- CAPSULE TENSION RING INSERTER, MODEL 7-810
- Applicant
- Duckworth & Kent, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-13
- Decision date
- 2004-12-28
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- NCE
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Baldock, Hertfordshire, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EASY CONTROL MICRO INSERTER, MODEL ON385 (K011498) | Ophtec USA, Inc. | 2001-07-09 |
| GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING (K001125) | Geuder GmbH | 2000-10-04 |
Recalls involving this device
No recalls on record reference this clearance.