The following data is part of a premarket notification filed by Kdi Med Supply with the FDA for 3 Ply Medical Grade Single Use Procedural Disposable Face Mask.
| Device ID | K220637 |
| 510k Number | K220637 |
| Device Name: | 3 Ply Medical Grade Single Use Procedural Disposable Face Mask |
| Classification | Mask, Surgical |
| Applicant | KDI Med Supply 206 Lynn St Fremont, OH 43420 |
| Contact | Yolanda Davis |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-03-25 |