EMG AC/DC SUCTION UNIT
FDA 510(k) clearance K063448 · decided 2006-11-30
Clearance details
- K-number
- K063448
- Device name
- EMG AC/DC SUCTION UNIT
- Applicant
- Emg Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-11-15
- Decision date
- 2006-11-30
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shituen Chiu, Taichung, TW
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.