The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kc 300 Surgical Mask.
| Device ID | K131879 |
| 510k Number | K131879 |
| Device Name: | KC 300 SURGICAL MASK |
| Classification | Mask, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Monica King |
| Correspondent | Monica King KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-24 |
| Decision Date | 2013-12-20 |
| Summary: | summary |