The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimguard Smart-fold Sterilization Wrap.
| Device ID | K140963 |
| 510k Number | K140963 |
| Device Name: | KIMGUARD SMART-FOLD STERILIZATION WRAP |
| Classification | Wrap, Sterilization |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Thomas Kozma, Ph.d. |
| Correspondent | Thomas Kozma, Ph.d. 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 | 2014-04-15 |
| Decision Date | 2014-11-10 |
| Summary: | summary |