SAF-T-SYRINGE- 0.5 AND 1ML/CC— 510(k) K063340
Substantially EquivalentSafety Medical International, Incorporated
FDA 510(k) clearance K063340 for SAF-T-SYRINGE- 0.5 AND 1ML/CC, Substantially Equivalent on 2007-03-06. Applicant: Safety Medical International, Incorporated.
Clearance details
- Applicant
- Safety Medical International, Incorporated
- Product code
- Code MEG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
Adverse 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.