The following data is part of a premarket notification filed by Shandong Haidike Medical Products Co., Ltd. with the FDA for Surgical Face Mask.
| Device ID | K210518 |
| 510k Number | K210518 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Shandong Haidike Medical Products Co., Ltd. Tianfu Road,Dongcheng District,Shan County Heze, CN 274300 |
| Contact | Lili Xu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 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 | 2021-02-23 |
| Decision Date | 2021-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971642801796 | K210518 | 000 |
| 06971642801789 | K210518 | 000 |