MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE
FDA 510(k) clearance K862863 · decided 1986-10-24
Clearance details
- K-number
- K862863
- Device name
- MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE
- Applicant
- Directed Energy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-29
- Decision date
- 1986-10-24
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.