The following data is part of a premarket notification filed by Dukal Corporation with the FDA for Dukal Corporation Sterile Aami Level 3 Reinforced Surgical Gown, Dukal Corporation Non-sterile Aami Level 3 Reinforced Surgical Gown, Dukal Corporation Sterile Aami Level 4 Surgical Gown, Dukal Corporation Non-sterile Aami Level 4 Surgical Gown.
| Device ID | K203237 |
| 510k Number | K203237 |
| Device Name: | Dukal Corporation Sterile AAMI Level 3 Reinforced Surgical Gown, Dukal Corporation Non-Sterile AAMI Level 3 Reinforced Surgical Gown, Dukal Corporation Sterile AAMI Level 4 Surgical Gown, Dukal Corporation Non-Sterile AAMI Level 4 Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Dukal Corporation 2 Fleetwood Court Ronkonkoma, NY 11779 |
| Contact | Megan Quevedo |
| Correspondent | Megan Quevedo Dukal Corporation 2 Fleetwood Court Ronkonkoma, NY 11779 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-03 |
| Decision Date | 2022-03-18 |