Tyvek® Pouch/Roll with STERRAD® Chemical Indicator— 510(k) K141693
Substantially EquivalentAdvanced Sterilization Products
FDA 510(k) clearance K141693 for Tyvek® Pouch/Roll with STERRAD® Chemical Indicator, Substantially Equivalent on 2014-12-19. Applicant: Advanced Sterilization Products.
Clearance details
- Applicant
- Advanced Sterilization Products
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvin, CA, US
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
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.