SUPERDIMENSION/BRONCHUS PREMIUM
FDA 510(k) clearance K052852 · decided 2005-11-14
Clearance details
- K-number
- K052852
- Device name
- SUPERDIMENSION/BRONCHUS PREMIUM
- Applicant
- Superdimension, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-11
- Decision date
- 2005-11-14
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hasbrouck Heights, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| superDimension Bronchus System (AAS00016-01), an image-guided localization system used to recall (Z-0666-2007) | SuperDimension, Inc. | 2007-03-29 |