The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimguard One-step Sterilization Wrap.
| Device ID | K112805 |
| 510k Number | K112805 |
| Device Name: | KIMGUARD ONE-STEP STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. BUILDING 300 Roswell, GA 30076 |
| Contact | Brenda Shelkey |
| Correspondent | Brenda Shelkey KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. BUILDING 300 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 | 2011-09-27 |
| Decision Date | 2012-06-22 |
| Summary: | summary |