The following data is part of a premarket notification filed by Zhejiang Lanhine Medical Products Ltd with the FDA for Level 3 Fluid Resistant Procedure/surgical Mask (model:15604f, 1570f).
| Device ID | K211827 |
| 510k Number | K211827 |
| Device Name: | Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) |
| Classification | Mask, Surgical |
| Applicant | Zhejiang Lanhine Medical Products LTD 1989 Cidong Road, Cidongbinhai District Cixi, CN 315300 |
| Contact | Jerry Gu |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-14 |
| Decision Date | 2021-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971513689515 | K211827 | 000 |
| 06971513688150 | K211827 | 000 |
| 16971513688171 | K211827 | 000 |
| 16971513688164 | K211827 | 000 |
| 06971513688181 | K211827 | 000 |