CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
FDA 510(k) clearance K080791 · decided 2008-04-30
Clearance details
- K-number
- K080791
- Device name
- CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
- Applicant
- Senorx, Inc.
- Decision
- Unknown
- Date received
- 2008-03-20
- Decision date
- 2008-04-30
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Aliso Viejo, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.