The following data is part of a premarket notification filed by Owens & Minor (o&m) Halyard, Inc. with the FDA for Halyard One-step Sterilization Wrap, Halyard Quick Check Sterilization Wrap.
| Device ID | K214007 |
| 510k Number | K214007 |
| Device Name: | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap |
| Classification | Wrap, Sterilization |
| Applicant | Owens & Minor (O&M) Halyard, Inc. 9120 Lockwood Blvd Mechanicsville, VA 23116 |
| Contact | Anureet Singh |
| Correspondent | Anureet Singh Owens & Minor (O&M) Halyard, Inc. 9120 Lockwood Blvd Mechanicsville, VA 23116 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-22 |
| Decision Date | 2022-07-27 |