SKIASCOPIC RACKS
FDA 510(k) clearance K844364 · decided 1985-01-02
Clearance details
- K-number
- K844364
- Device name
- SKIASCOPIC RACKS
- Applicant
- Luneau Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1984-11-13
- Decision date
- 1985-01-02
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HMH
- Device class
- 1
- Regulation number
- 886.1750
- 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 |
|---|---|---|
| VISITEC FLIERINGA-LEGRAND FIXATION RING (K843195) | Visitec Co. | 1984-10-05 |
Recalls involving this device
No recalls on record reference this clearance.