Barrier Supreme Sterilization Wrapper— 510(k) K162162
Substantially EquivalentStandard Textile Co., Inc.
FDA 510(k) clearance K162162 for Barrier Supreme Sterilization Wrapper, Substantially Equivalent on 2016-11-04. Applicant: Standard Textile Co., Inc..
Clearance details
- Applicant
- Standard Textile Co., Inc.
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, 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.