BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.— 510(k) K885019
Substantially EquivalentBemis Health Care
FDA 510(k) clearance K885019 for BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI., Substantially Equivalent on 1989-01-25. Applicant: Bemis Health Care.
Clearance details
- Applicant
- Bemis Health Care
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sheboygan Falls, WI, 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.