The following data is part of a premarket notification filed by Little Rapids Corporation with the FDA for Procedure Mask.
| Device ID | K220377 |
| 510k Number | K220377 |
| Device Name: | Procedure Mask |
| Classification | Mask, Surgical |
| Applicant | Little Rapids Corporation 2273 Larsen Road Green Bay, WI 54303 |
| Contact | Tom Diedrich |
| Correspondent | Tom Diedrich Little Rapids Corporation 2273 Larsen Road Green Bay, WI 54303 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-10 |
| Decision Date | 2022-06-24 |