Device Listing 1642068807
Listing Summary#
- Listing key
- 1642068807
- Premarket submission
- K232812
- Device
- Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
- Product code
- FXX
- Decision date
- 2024-06-14