The following data is part of a premarket notification filed by O&m Halyard, Inc with the FDA for Aero Chrome* Select Breathable Performance Surgical Gown, Aero Chrome* A-line Breathable Performance Surgical Gown.
| Device ID | K210688 |
| 510k Number | K210688 |
| Device Name: | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown |
| 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 | 2021-03-08 |
| Decision Date | 2021-07-21 |