SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC— 510(k) K070117
Substantially EquivalentDolomite Biotech Sdn Bhd
FDA 510(k) clearance K070117 for SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC, Substantially Equivalent on 2007-08-06. Applicant: Dolomite Biotech Sdn Bhd.
Clearance details
- Applicant
- Dolomite Biotech Sdn Bhd
- Product code
- Code MEG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Leandro, CA, 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.