The following data is part of a premarket notification filed by Handan Hengyong Protective & Clean Products Co., L with the FDA for Handan N95 Particulate Respirators And Surgical Mask, Models Hy8510 And Hy9810.
| Device ID | K080827 |
| 510k Number | K080827 |
| Device Name: | HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 |
| Classification | Respirator, Surgical |
| Applicant | HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L 1-1-1201, 455 GONGNONG ROAD Shijiazhuang, Hebei Province, CN 050051 |
| Contact | Maggie Zhong |
| Correspondent | Maggie Zhong HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L 1-1-1201, 455 GONGNONG ROAD Shijiazhuang, Hebei Province, CN 050051 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-25 |
| Decision Date | 2008-04-04 |
| Summary: | summary |