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 | K143053 |
| 510k Number | K143053 |
| Device Name: | KIMGUARD ONE-STEP Sterilization Wrap |
| Classification | Wrap, Sterilization |
| Applicant | KIMBERLY-CLARK HEALTH CARE 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Contact | Monica King |
| Correspondent | Monica King KIMBERLY-CLARK HEALTH CARE 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-23 |
| Decision Date | 2015-04-03 |
| Summary: | summary |