INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES— 510(k) K092413
Substantially EquivalentInviro Medical Devices, Inc.
FDA 510(k) clearance K092413 for INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES, Substantially Equivalent on 2009-09-04. Applicant: Inviro Medical Devices, Inc..
Clearance details
- Applicant
- Inviro Medical Devices, Inc.
- Product code
- Code MEG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lawrenceville, GA, 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.