TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER— 510(k) K053430
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K053430 for TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER, Substantially Equivalent on 2006-03-03. Applicant: Medtronic Xomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Code HKY
- Device class
- Class 2
- Regulation
- 21 CFR 886.1930
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.