The following data is part of a premarket notification filed by Sq Medical Supplies Inc. with the FDA for Surgical Masks, Model Snn200640 & Mn112.
Device ID | K203776 |
510k Number | K203776 |
Device Name: | Surgical Masks, Model SNN200640 & MN112 |
Classification | Mask, Surgical |
Applicant | SQ Medical Supplies Inc. 8889 West Olympic Blvd. Suite 1000 Beverly Hills Beverly Hills, CA 90211 |
Contact | Jonathan Lim |
Correspondent | Shelly Li Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555 Shanghai, CN 200072 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-12-28 |
Decision Date | 2021-03-25 |