The following data is part of a premarket notification filed by Halyard Health, Inc. with the FDA for Fluidshield* Surgical Mask With Expanded Chamber.
| Device ID | K143287 |
| 510k Number | K143287 |
| Device Name: | Fluidshield* Surgical Mask With Expanded Chamber |
| Classification | Mask, Surgical |
| Applicant | Halyard Health, Inc. 5405 Windward Pkwy Alpharetta, GA 30004 |
| Contact | Roberto F. Refeca |
| Correspondent | Roberto F. Refeca Halyard Health, Inc. 5405 Windward Pkwy Alpharetta, GA 30004 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-17 |
| Decision Date | 2015-03-24 |
| Summary: | summary |