AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E— 510(k) K090914
UnknownXoft, Inc.
FDA 510(k) clearance K090914 for AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E, Unknown on 2009-07-16. Applicant: Xoft, Inc.. Device class: 2.
Clearance details
- Applicant
- Xoft, Inc.
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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