THE VISONIC DOME(TM)
FDA 510(k) clearance K902306 · decided 1990-12-21
Clearance details
- K-number
- K902306
- Device name
- THE VISONIC DOME(TM)
- Applicant
- Vista Vision
- Decision
- Substantially Equivalent
- Date received
- 1990-05-22
- Decision date
- 1990-12-21
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- LYL
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Marlboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.