STERRADD STERILIZATION SYSTEM— 510(k) K954142
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K954142 for STERRADD STERILIZATION SYSTEM, Substantially Equivalent on 1997-06-06. Applicant: Advanced Sterilization Products.
Clearance details
- Applicant
- Advanced Sterilization Products
- Product code
- Code FLE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, 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.