DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES
FDA 510(k) clearance K072789 · decided 2007-10-19
Clearance details
- K-number
- K072789
- Device name
- DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES
- Applicant
- Encision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-01
- Decision date
- 2007-10-19
- Days to decision
- 18 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
- Boulder, CO, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.