SCIENTRONICS 10K EYE MAGNET
FDA 510(k) clearance K832950 · decided 1983-10-19
Clearance details
- K-number
- K832950
- Device name
- SCIENTRONICS 10K EYE MAGNET
- Applicant
- Scientific Manufacturer
- Decision
- Substantially Equivalent
- Date received
- 1983-08-31
- Decision date
- 1983-10-19
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- HPO
- Device class
- 2
- Regulation number
- 886.4440
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, 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 |
|---|---|---|
| INTRAOCULAR ELECTROMAGNET (K854870) | Mira, Inc. | 1986-02-19 |
| DORC INTRAOCULAR ELECTROMAGNET (K830336) | Jedmed Instrument Co. | 1983-03-09 |
Recalls involving this device
No recalls on record reference this clearance.