GOODE T-TUBE, BIOLITE COATED SILICONE/TU
FDA 510(k) clearance K800727 · decided 1980-04-16
Clearance details
- K-number
- K800727
- Device name
- GOODE T-TUBE, BIOLITE COATED SILICONE/TU
- Applicant
- Xomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-01
- Decision date
- 1980-04-16
- Days to decision
- 15 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
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.