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 |