LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP— 510(k) K090830
Substantially EquivalentLaborie Medical Technologies, Ltd.
FDA 510(k) clearance K090830 for LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP, Substantially Equivalent on 2009-07-21. Applicant: Laborie Medical Technologies, Ltd..
Clearance details
- Applicant
- Laborie Medical Technologies, Ltd.
- Product code
- Code FBK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Williston, VT, US
Adverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
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.