IDRIVE ULTRA STERILIZATION TRAY— 510(k) K130532
Substantially EquivalentCovidien, Formerly US Surgical A Divison of Tyco H
FDA 510(k) clearance K130532 for IDRIVE ULTRA STERILIZATION TRAY, Substantially Equivalent on 2013-05-30. Applicant: Covidien, Formerly US Surgical A Divison of Tyco H. Device class: 2.
Clearance details
- Applicant
- Covidien, Formerly US Surgical A Divison of Tyco H
- Product code
- Code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Haven, CT, US
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