The following data is part of a premarket notification filed by Halyard Health with the FDA for Kimguard One Step Sterilization Wrap.
| Device ID | K141712 |
| 510k Number | K141712 |
| Device Name: | KIMGUARD ONE STEP STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | Halyard Health 1400 MARSHALL ST. NE Minneapolis, MN 55413 |
| Contact | Thomas Kozma |
| Correspondent | Thomas Kozma Halyard Health 1400 MARSHALL ST. NE 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 | 2014-06-25 |
| Decision Date | 2014-12-18 |
| Summary: | summary |