The following data is part of a premarket notification filed by Unicoglobal, Inc. with the FDA for Unico Global Level 3 Surgical Gown (film-reinforced Sms), Unico Global Level 3 Surgical Gown (pp+pe).
| Device ID | K203539 |
| 510k Number | K203539 |
| Device Name: | Unico Global Level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) |
| Classification | Gown, 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-03 |
| Decision Date | 2021-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809783490297 | K203539 | 000 |
| 08809783490181 | K203539 | 000 |
| 08809783490174 | K203539 | 000 |
| 08809783490167 | K203539 | 000 |
| 08809783490150 | K203539 | 000 |
| 08809783490143 | K203539 | 000 |
| 08809783490136 | K203539 | 000 |
| 08809783490129 | K203539 | 000 |
| 08809783490112 | K203539 | 000 |
| 08809783490198 | K203539 | 000 |
| 08809783490204 | K203539 | 000 |
| 08809783490280 | K203539 | 000 |
| 08809783490273 | K203539 | 000 |
| 08809783490266 | K203539 | 000 |
| 08809783490259 | K203539 | 000 |
| 08809783490242 | K203539 | 000 |
| 08809783490235 | K203539 | 000 |
| 08809783490228 | K203539 | 000 |
| 08809783490211 | K203539 | 000 |
| 08809783490105 | K203539 | 000 |