The following data is part of a premarket notification filed by O&m Halyard, Inc with the FDA for Aero Chrome* Breathable Performance Surgical Gowns.
Device ID | K200522 |
510k Number | K200522 |
Device Name: | AERO CHROME* Breathable 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 | 2020-03-02 |
Decision Date | 2020-03-16 |