EASY CONTROL MICRO INSERTER, MODEL ON385
FDA 510(k) clearance K011498 · decided 2001-07-09
Clearance details
- K-number
- K011498
- Device name
- EASY CONTROL MICRO INSERTER, MODEL ON385
- Applicant
- Ophtec USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-15
- Decision date
- 2001-07-09
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- NCE
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Boca Raton, FL, US
- 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 |
|---|---|---|
| CAPSULE TENSION RING INSERTER, MODEL 7-810 (K042478) | Duckworth & Kent, Ltd. | 2004-12-28 |
| GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING (K001125) | Geuder GmbH | 2000-10-04 |
Recalls involving this device
No recalls on record reference this clearance.