The following data is part of a premarket notification filed by Sichuan Pharmaceutical. Inc. with the FDA for Medical Surgical Mask.
| Device ID | K210813 |
| 510k Number | K210813 |
| Device Name: | Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Sichuan Pharmaceutical. Inc. Sichuan Pharmaceutical. Inc. No. 18 Baiye Road, Hi-Tech West Zone Sichuan, CN 611731 |
| Contact | Yunrui Zhang |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-17 |
| Decision Date | 2021-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06941548900176 | K210813 | 000 |