Tyvek Sterilization Pouches with Chevron Seal— 510(k) K152058
Substantially EquivalentAndersen Sterilizers, Inc.
FDA 510(k) clearance K152058 for Tyvek Sterilization Pouches with Chevron Seal, Substantially Equivalent on 2015-11-18. Applicant: Andersen Sterilizers, Inc..
Clearance details
- Applicant
- Andersen Sterilizers, Inc.
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haw River, NC, 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.