The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimguard One-step Sterilization Wrap, Models Kc100, Kc200, Kc300, Kc400, Kc500, Kc600.
| Device ID | K092167 |
| 510k Number | K092167 |
| Device Name: | KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 |
| Classification | Wrap, Sterilization |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Thomas Kozma |
| Correspondent | Thomas Kozma KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. 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 | 2009-07-21 |
| Decision Date | 2009-11-02 |
| Summary: | summary |