MODIFIED MYDRIATIC SPECTACLE
FDA 510(k) clearance K854140 · decided 1985-12-17
Clearance details
- K-number
- K854140
- Device name
- MODIFIED MYDRIATIC SPECTACLE
- Applicant
- La Rue Optical
- Decision
- Substantially Equivalent
- Date received
- 1985-10-10
- Decision date
- 1985-12-17
- Days to decision
- 68 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Dover, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.