ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
FDA 510(k) clearance K080838 · decided 2008-04-24
Clearance details
- K-number
- K080838
- Device name
- ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
- Applicant
- Alveolus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-25
- Decision date
- 2008-04-24
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- ESW
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Charlotte, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.