Device Listing 1697352478

Listing Summary#

Listing key
1697352478
Premarket submission
K253454
Device
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap
Applicant
O&M Halyard, Inc.
Product code
FRG
Decision date
2026-05-18