MAGNILINK SYSTEM 402/5
FDA 510(k) clearance K892350 · decided 1989-05-26
Clearance details
- K-number
- K892350
- Device name
- MAGNILINK SYSTEM 402/5
- Applicant
- Coburn Optical Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-05
- Decision date
- 1989-05-26
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- HJG
- Device class
- 1
- Regulation number
- 886.5820
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Tulsa, OK, 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 |
|---|---|---|
| LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE (K933633) | Gracefully Yours, Inc. | 1994-02-22 |
| MENTOR HORIZON LOW VISION MAGNIFIER (K915340) | Mentor O & O, Inc. | 1992-03-30 |
| MAGNI-CAM (K920069) | Innoventions, Inc. | 1992-03-02 |
| MAGNILINK SYSTEM 602 (K892351) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 101 (K892347) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 201 (K892348) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 209 (K892349) | Coburn Optical Ind., Inc. | 1989-05-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NEODYMIUM-YAG OP LASER OPL-3 (P830064/S003) | Coburn Optical Ind., Inc. | 1986-05-28 |
| NEODYMIUM-YAG OP LASER OPL-3 (P830064/S001) | Coburn Optical Ind., Inc. | 1985-02-06 |
| NEODYMIUM-YAG OP LASER OPL-3 (P830064/S002) | Coburn Optical Ind., Inc. | 1984-12-13 |