HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)— 510(k) K240330
Substantially EquivalentO&M Halyard, Inc.
FDA 510(k) clearance K240330 for HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650), Substantially Equivalent on 2024-08-07. Applicant: O&M Halyard, Inc..
Clearance details
- Applicant
- 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.