SUPRAFLOW CONSOLE
FDA 510(k) clearance K040239 · decided 2004-02-17
Clearance details
- K-number
- K040239
- Device name
- SUPRAFLOW CONSOLE
- Applicant
- Neomedix Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-02
- Decision date
- 2004-02-17
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Juan Capistrano, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator recall (Z-0071-2008) | Neomedix Corp | 2008-09-29 |