The following data is part of a premarket notification filed by Kimberly-clark Health Care with the FDA for Kimguard One Step Sterilization Wrap.
| Device ID | K113806 |
| 510k Number | K113806 |
| Device Name: | KIMGUARD ONE STEP STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | KIMBERLY-CLARK HEALTH CARE 33 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Contact | Christopher B Swanson |
| Correspondent | Christopher B Swanson KIMBERLY-CLARK HEALTH CARE 33 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2013-08-20 |
| Summary: | summary |