The following data is part of a premarket notification filed by Promedica Products, Inc. with the FDA for C-mask.
| Device ID | K882882 |
| 510k Number | K882882 |
| Device Name: | C-MASK |
| Classification | Mask, Surgical |
| Applicant | PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach, CA 92660 |
| Contact | Lee Hand |
| Correspondent | Lee Hand PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach, CA 92660 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-11 |
| Decision Date | 1988-08-10 |