The following data is part of a premarket notification filed by Jiangxi 3l Medical Products Group Co., Ltd with the FDA for Surgical Face Mask.
Device ID | K202277 |
510k Number | K202277 |
Device Name: | Surgical Face Mask |
Classification | Mask, Surgical |
Applicant | Jiangxi 3L Medical Products Group Co., Ltd No.599, Huoju Street, High-tech Development Zone Nanchang City, CN 330029 |
Contact | Ge Zhang |
Correspondent | Charles Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-11 |
Decision Date | 2020-09-25 |