The following data is part of a premarket notification filed by Allmed Medical Products Co., Ltd with the FDA for Allmed Surgical Face Masks (ear Loops).
Device ID | K202128 |
510k Number | K202128 |
Device Name: | Allmed Surgical Face Masks (Ear Loops) |
Classification | Mask, Surgical |
Applicant | Allmed Medical Products Co., LTD No. 180 Gongyuan Road Majiadian Town Zhijiang, CN 443200 |
Contact | Vince Tian |
Correspondent | Vince Tian Allmed Medical Products Co., LTD No. 180 Gongyuan Road Majiadian Town Zhijiang, CN 443200 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-31 |
Decision Date | 2021-06-03 |