BINOCULAR LOUPE
FDA 510(k) clearance K830878 · decided 1983-04-06
Clearance details
- K-number
- K830878
- Device name
- BINOCULAR LOUPE
- Applicant
- Almore Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-18
- Decision date
- 1983-04-06
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- HJH
- Device class
- 1
- Regulation number
- 886.5120
- 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 |
|---|---|---|
| MALIS SURGICAL LOUPES (K874845) | Valley Forge Scientific Corp. | 1987-12-23 |
| EXETER OPERATING LOUPE (K863983) | Exeter Instruments, Inc. | 1986-11-10 |
Recalls involving this device
No recalls on record reference this clearance.