CONTACT LENS LOUPE, INSPETION LOUPE
FDA 510(k) clearance K852054 · decided 1985-09-05
Clearance details
- K-number
- K852054
- Device name
- CONTACT LENS LOUPE, INSPETION LOUPE
- Applicant
- Ascon Medical Instruments, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-09
- Decision date
- 1985-09-05
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- HLN
- Device class
- 1
- Regulation number
- 886.1420
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Westmont, 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 |
|---|---|---|
| LEIGH MEASURING SCALE #7725 (K801466) | Edward Weck, Inc. | 1980-07-28 |
Recalls involving this device
No recalls on record reference this clearance.