SPECTACLE, MAGNIFYING
FDA 510(k) clearance K873967 · decided 1988-02-26
Clearance details
- K-number
- K873967
- Device name
- SPECTACLE, MAGNIFYING
- Applicant
- Swank Plus , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-29
- Decision date
- 1988-02-26
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- HOT
- Device class
- 1
- Regulation number
- 886.5910
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Hong Kong, HK
- 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 |
|---|---|---|
| VIEWSCAN (K863994) | Sensory Aids Corp. | 1986-10-31 |
Recalls involving this device
No recalls on record reference this clearance.