The following data is part of a premarket notification filed by Kimberly-clark with the FDA for Kc200, Surgical Mask, Kc200, Procedure Mask, Kc300, Surgicalmask, Fluidshield, Kc300, Procedure Mask, Fluidshield Model.
| Device ID | K111402 |
| 510k Number | K111402 |
| Device Name: | KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL |
| Classification | Mask, Surgical |
| Applicant | KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Contact | Ann Waterhouse, Rac |
| Correspondent | Ann Waterhouse, Rac KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-19 |
| Decision Date | 2011-10-20 |
| Summary: | summary |