KOI LACREMAL HOOK & DILATOR
FDA 510(k) clearance K812097 · decided 1981-08-18
Clearance details
- K-number
- K812097
- Device name
- KOI LACREMAL HOOK & DILATOR
- Applicant
- Koi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-24
- Decision date
- 1981-08-18
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- HNW
- Device class
- 1
- Regulation number
- 886.4350
- 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 |
|---|---|---|
| INTER-SHARP (K862070) | Intermedics Intraocular, Inc. | 1986-06-17 |
| LACHRYMAL PROBES-VARIOUS (K841002) | Premier Dental Products Co. | 1984-05-09 |
Recalls involving this device
No recalls on record reference this clearance.