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 |