ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
FDA 510(k) clearance K091816 · decided 2009-07-01
Clearance details
- K-number
- K091816
- Device name
- ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-06-18
- Decision date
- 2009-07-01
- Days to decision
- 13 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
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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