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.
| Device ID | K192147 |
| 510k Number | K192147 |
| Device Name: | Halyard ONE-STEP* Sterilization Wrap |
| Classification | Wrap, Sterilization |
| Applicant | Owens & Minor (O&M) Halyard, Inc 9120 Lockwood Blvd Mechanicsville, VA 23116 |
| Contact | Steven Dowdley |
| Correspondent | Peter Kalkbrenner Peter R Kalkbrenner Sterilucent, Inc Minneapolis, MN 55413 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-08 |
| Decision Date | 2019-10-10 |
| Summary: | summary |