The following data is part of a premarket notification filed by O&m Halyard, Inc. with the FDA for Aero Blue Performance Surgical Gowns.
| Device ID | K192362 |
| 510k Number | K192362 |
| Device Name: | Aero Blue Performance Surgical Gowns |
| Classification | Gown, Surgical |
| Applicant | O&M Halyard, Inc. 9120 Lockwood Blvd Mechanicsville, VA 23116 |
| Contact | Kimberly Lewis |
| Correspondent | Kimberly Lewis O&M Halyard, Inc. 9120 Lockwood Blvd Mechanicsville, VA 23116 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2019-12-13 |