The following data is part of a premarket notification filed by Dukal Corporation with the FDA for Dukal Corporation Level 2 Surgical Mask With Ear Loops; Dukal Corporation Level 2 Surgical Mask With Ear Loops And Face Shield; Dukal Corporation Level 2 Surgical Mask With Adjustable Tie Ons.
| Device ID | K201421 |
| 510k Number | K201421 |
| Device Name: | Dukal Corporation Level 2 Surgical Mask With Ear Loops; Dukal Corporation Level 2 Surgical Mask With Ear Loops And Face Shield; Dukal Corporation Level 2 Surgical Mask With Adjustable Tie Ons |
| Classification | Mask, 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 | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-29 |
| Decision Date | 2021-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20665973028891 | K201421 | 000 |