ILLUMINATED SPECULUM
FDA 510(k) clearance K801058 · decided 1980-05-28
Clearance details
- K-number
- K801058
- Device name
- ILLUMINATED SPECULUM
- Applicant
- Designs For Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-06
- Decision date
- 1980-05-28
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- FXF
- Device class
- 1
- Regulation number
- 878.1800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.