EXETER OPERATING LOUPE
FDA 510(k) clearance K810817 · decided 1981-04-23
Clearance details
- K-number
- K810817
- Device name
- EXETER OPERATING LOUPE
- Applicant
- Exeter Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-24
- Decision date
- 1981-04-23
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- HOH
- Device class
- 1
- Regulation number
- 886.4770
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| SURGITEL (K934494) | General Scientific Corp. | 1994-01-25 |
| LOW-POWER BINOCULAR LOUPE (K875124) | Seiler Instrument & Mfg. Co., Inc. | 1988-02-19 |
Recalls involving this device
No recalls on record reference this clearance.