FLUOROPLASTIC VENTILATION TUBES— 510(k) K992222
Substantially EquivalentGyrus Ent LLC
FDA 510(k) clearance K992222 for FLUOROPLASTIC VENTILATION TUBES, Substantially Equivalent on 1999-08-26. Applicant: Gyrus Ent LLC. Device class: 2.
Clearance details
- Applicant
- Gyrus Ent LLC
- 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
- Bartlett, TN, US
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- K033554 — SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
- K030343 — DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
Data sourced from openFDA. This site is unofficial and independent of the FDA.