BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML— 510(k) K041970
Substantially EquivalentBiotop Technology Co., Ltd.
FDA 510(k) clearance K041970 for BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML, Substantially Equivalent on 2004-08-03. Applicant: Biotop Technology Co., Ltd..
Clearance details
- Applicant
- Biotop Technology Co., Ltd.
- Product code
- Code MEG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hsin Chu City, TW
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.