Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
FDA 510(k) clearance K232807 · decided 2024-06-21
Clearance details
- K-number
- K232807
- Device name
- Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-12
- Decision date
- 2024-06-21
- Days to decision
- 283 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mechanicsville, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.