The following data is part of a premarket notification filed by Yts Global Inc. with the FDA for Technoweb Surgical Mask.
Device ID | K172500 |
510k Number | K172500 |
Device Name: | Technoweb Surgical Mask |
Classification | Mask, Surgical |
Applicant | YTS GLOBAL INC. 7406 ALBAN STATION CT STE A 108 Springfield, VA 22150 |
Contact | Eddie Nguyen |
Correspondent | Eddie Nguyen YTS GLOBAL INC. 7406 ALBAN STATION COURT SUITE A108 Springfield, VA 22150 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-18 |
Decision Date | 2018-03-01 |
Summary: | summary |