K934011
Substantially EquivalentMITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
- Applicant
- Neward Enterprises, Inc.
- Product code
- HDB
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cucamonga, CA, US
Adverse events under product code HDB
product code HDB- Death
- 7
- Total
- 7
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.