EMG MODEL SUA01 SUCTION UNIT
FDA 510(k) clearance K042349 · decided 2004-12-16
Clearance details
- K-number
- K042349
- Device name
- EMG MODEL SUA01 SUCTION UNIT
- Applicant
- Emg Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-30
- Decision date
- 2004-12-16
- Days to decision
- 108 days
- Clearance type
- Abbreviated
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Baltimore, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Emg Technology Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction uni recall (Z-2642-2014) | EMG Technology Co., Ltd. | 2014-09-13 |