The following data is part of a premarket notification filed by Cross Protection (m) Sdn Bhd with the FDA for Cross Protection Resq300 Plus Surgical Face Mask.
| Device ID | K212273 |
| 510k Number | K212273 |
| Device Name: | Cross Protection ResQ300 Plus Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Cross Protection (M) Sdn Bhd 11, JLN Perindustrian5, JLN Meru Klang, MY 41050 |
| Contact | Grace Tan |
| Correspondent | Grace Tan Cross Protection (M) Sdn Bhd 11, JLN Perindustrian5, JLN Meru Klang, MY 41050 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2022-08-17 |