TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)— 510(k) K031062
Substantially EquivalentTaiject Medical Device Co., Ltd.
FDA 510(k) clearance K031062 for TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN), Substantially Equivalent on 2003-05-02. Applicant: Taiject Medical Device Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Taiject Medical Device Co., Ltd.
- Product code
- Code MEG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newport Beach, CA, US
Recent devices under product code MEG
view allMore clearances from Taiject Medical Device Co., Ltd.
view allAdverse events under product code MEG
product code MEG- Malfunction
- 1,373
- Other
- 1
- Total
- 1,374
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.