TANNE CORNEAL CUTTING BLOCK
FDA 510(k) clearance K871646 · decided 1987-05-18
Clearance details
- K-number
- K871646
- Device name
- TANNE CORNEAL CUTTING BLOCK
- Applicant
- Ocular Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-28
- Decision date
- 1987-05-18
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- HNJ
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Bellevue, WA, 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 |
|---|---|---|
| DORC CORNEAL PUNCH BLOCK (K830335) | Jedmed Instrument Co. | 1983-03-09 |
| REPL. PISTON FOR TROUTMAN CORNEAL PUNCH (K791988) | Edward Weck, Inc. | 1979-10-30 |
Recalls involving this device
No recalls on record reference this clearance.