The following data is part of a premarket notification filed by Owens& Minor Halyard, Inc. with the FDA for Halyard Smart-fold* Sterilization Wrap (h450, H650).
| Device ID | K181959 |
| 510k Number | K181959 |
| Device Name: | HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) |
| Classification | Wrap, Sterilization |
| Applicant | Owens& Minor Halyard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Shriya Kafle |
| Correspondent | Angela L Bunn Owens& Minor Halyard, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-23 |
| Decision Date | 2019-03-22 |