SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH— 510(k) K130357
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K130357 for SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH, Substantially Equivalent on 2013-11-06. Applicant: Covidien, LLC. Device class: 2.
Clearance details
- Applicant
- Covidien, LLC
- Product code
- Code BTG
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.