510(k) K823457— NON-PRESSURE AUTOCLAVE FOR STERILIZATION
Substantially EquivalentInterdent, Inc.
Clearance details
- Applicant
- Interdent, Inc.
- Product code
- Code FLE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
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.