Halyard ONE-STEP* Sterilization Wrap— 510(k) K192147
Substantially EquivalentOwens & Minor (O&M) Halyard, Inc.
FDA 510(k) clearance K192147 for Halyard ONE-STEP* Sterilization Wrap, Substantially Equivalent on 2019-10-10. Applicant: Owens & Minor (O&M) Halyard, Inc..
Clearance details
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
- Product code
- Code FRG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mechanicsville, VA, 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.