The following data is part of a premarket notification filed by 3a Medical Products Co., Ltd with the FDA for 3 Layer Surgical Mask With Ear Loops Level 1, 3 Layer Surgical Mask With Ties Level 1, 3 Layer Surgical Mask With Ear Loops Level 2, 3 Layer Surgical Mask With Ties Level 2, 3 Layer Surgical Mask With Ear Loops Level 3, 3 Layer Surgical Marks With Ti.
| Device ID | K202598 |
| 510k Number | K202598 |
| Device Name: | 3 Layer Surgical Mask With Ear Loops Level 1, 3 Layer Surgical Mask With Ties Level 1, 3 Layer Surgical Mask With Ear Loops Level 2, 3 Layer Surgical Mask With Ties Level 2, 3 Layer Surgical Mask With Ear Loops Level 3, 3 Layer Surgical Marks With Ti |
| Classification | Mask, Surgical |
| Applicant | 3A Medical Products Co., Ltd Yu An Industrial Park 230001 Liu An, CN |
| Contact | Slinda Ma |
| Correspondent | Mary Mejaes 3A Medical Products Co., Ltd Yu An Industrial Park 230001 Liu An, CN |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2021-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009046450 | K202598 | 000 |