Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)— 510(k) K253580
Substantially EquivalentTedan Surgical Innovations
FDA 510(k) clearance K253580 for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S), Substantially Equivalent on 2026-04-26. Applicant: Tedan Surgical Innovations. Device class: 2.
Clearance details
- Applicant
- Tedan Surgical Innovations
- Product code
- Code PDQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sugar Land, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.