SURGIMAX/ SURGIMAX PLUS
FDA 510(k) clearance K100390 · decided 2010-08-25
Clearance details
- K-number
- K100390
- Device name
- SURGIMAX/ SURGIMAX PLUS
- Applicant
- Elliquence, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-02-16
- Decision date
- 2010-08-25
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.