MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
FDA 510(k) clearance K874963 · decided 1987-12-23
Clearance details
- K-number
- K874963
- Device name
- MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
- Applicant
- Solway, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-02
- Decision date
- 1987-12-23
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- HNA
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Hollywood, 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 |
|---|---|---|
| MSP OPHTHALMIC (EYE SPUD) (K931449) | Medical Sterile Products, Inc. | 1993-08-31 |
Recalls involving this device
No recalls on record reference this clearance.