VIVAWAVE MICROWAVE SYSTEM
FDA 510(k) clearance K011676 · decided 2002-06-18
Clearance details
- K-number
- K011676
- Device name
- VIVAWAVE MICROWAVE SYSTEM
- Applicant
- Vivant Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-30
- Decision date
- 2002-06-18
- Days to decision
- 384 days
- Clearance type
- Traditional
- Product code
- NEY
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Hea recall (Z-3092-2011) | Covidien, PLC | 2011-08-30 |