The following data is part of a premarket notification filed by Unicoglobal, Inc. with the FDA for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask With Face Shield.
Device ID | K210147 |
510k Number | K210147 |
Device Name: | Unico High Performance Surgical Mask, Unico High Performance Surgical Mask With Face Shield |
Classification | Mask, Surgical |
Applicant | Unicoglobal, Inc. #904, Woolim Pangyo W-City 9-22, Pangyo-Ro 255bion-Gil Bundang-gu Seongnam, KR 13486 |
Contact | Yoonsok Park |
Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, CA 92620 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-21 |
Decision Date | 2021-12-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08809783490518 | K210147 | 000 |
08809783490501 | K210147 | 000 |
08809783490099 | K210147 | 000 |
08809783490082 | K210147 | 000 |