TOP FINE INSULIN SYRINGE— 510(k) K063348
Substantially EquivalentDaejin Tech Medical Manufacturing Co., Ltd.
FDA 510(k) clearance K063348 for TOP FINE INSULIN SYRINGE, Substantially Equivalent on 2007-03-01. Applicant: Daejin Tech Medical Manufacturing Co., Ltd..
Clearance details
- Applicant
- Daejin Tech Medical Manufacturing Co., Ltd.
- Product code
- Code FMF
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deer Field, IL, US
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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.