FLUOROPLASTIC VENTILATION TUBES
FDA 510(k) clearance K992222 · decided 1999-08-26
Clearance details
- K-number
- K992222
- Device name
- FLUOROPLASTIC VENTILATION TUBES
- Applicant
- Gyrus Ent LLC
- Decision
- Substantially Equivalent
- Date received
- 1999-07-01
- Decision date
- 1999-08-26
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- ETD
- Device class
- 2
- Regulation number
- 874.3880
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bartlett, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.