1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1— 510(k) K100998
Substantially EquivalentUnilife Medical Solutions Limited
FDA 510(k) clearance K100998 for 1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1, Substantially Equivalent on 2010-08-30. Applicant: Unilife Medical Solutions Limited. Device class: 2.
Clearance details
- Applicant
- Unilife Medical Solutions Limited
- 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
- Traditional
- Location
- Lewisberry, PA, US
Recent devices under product code MEG
view allMore clearances from Unilife Medical Solutions Limited
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.