HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER— 510(k) K963727
Substantially EquivalentMedtronic Xomed
FDA 510(k) clearance K963727 for HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER, Substantially Equivalent on 1997-02-11. Applicant: Medtronic Xomed. Device class: 2.
Clearance details
- Applicant
- Medtronic Xomed
- Product code
- Code ETD
- Device class
- Class 2
- Regulation
- 21 CFR 874.3880
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
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