The following data is part of a premarket notification filed by Lhm Medical Technology (hong Kong) Limited with the FDA for Disposable Surgical Mask/fluid Resistant Procedure Mask.
| Device ID | K202240 |
| 510k Number | K202240 |
| Device Name: | Disposable Surgical Mask/Fluid Resistant Procedure Mask |
| Classification | Mask, Surgical |
| Applicant | LHM Medical Technology (Hong Kong) Limited Unit No. 2, 3/F., Block A, Ko Fai Industrial Building, 7 Ko Fai Road,Yau Tong Hongkong, CN 999077 |
| Contact | Frank Cheng |
| Correspondent | Frank Cheng LHM Medical Technology (Hong Kong) Limited Unit No. 2, 3/F., Block A, Ko Fai Industrial Building, 7 Ko Fai Road,Yau Tong Hongkong, CN 999077 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-10 |
| Decision Date | 2021-02-25 |