LENS
FDA 510(k) clearance K821897 · decided 1983-01-05
Clearance details
- K-number
- K821897
- Device name
- LENS
- Applicant
- Mortan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-28
- Decision date
- 1983-01-05
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- KYG
- Device class
- 1
- Regulation number
- 886.4360
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| MED-LOGICS DISPOSABLE ALK TUBING (K010353) | Med-Logics, Inc. | 2001-04-27 |
| TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 (K003036) | Retinalabs.Com | 2000-12-22 |
| BLADEWORKS DISPOSABLE ALK TUBING (K993591) | Blade Works, Inc. | 1999-12-28 |
| SOVEREIGN CATARACT EXTRACTION SYSTEM (K981116) | Allergan, Inc. | 1998-05-19 |
| EYE IRRIGATOR MODEL #2020 (K980647) | Eye-Deal Ocular Safety Products, Inc. | 1998-05-15 |
| MOISTAIR FLUID AIR TUBING SET (K974561) | American Medical Devices, Inc. | 1998-02-19 |
| ML DISPOSABLE ALK TUBING (K971173) | Med-Logics, Inc. | 1997-05-22 |
| HEDGES CORNEAL WETTING PAK (K970161) | Hedges Cwp, Inc. | 1997-03-25 |
| D.O.R.C. VFI/VFE SYSTEM (K954842) | Dutch Ophthalmic USA, Inc. | 1996-04-15 |
| DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (K945171) | Boston Surgical Products, Inc. | 1995-02-08 |
| PEREGRINE PIC MINIPULATOR (K940392) | Peregrine Surgical , Ltd. | 1994-08-23 |
| I/V POLE (K935226) | Optical Micro Systems, Inc. | 1994-02-16 |
Recalls involving this device
No recalls on record reference this clearance.