The following data is part of a premarket notification filed by Foshan Nanhai Plus Medical Co Ltd with the FDA for Plus Medical Cover Gown.
| Device ID | K213177 |
| 510k Number | K213177 |
| Device Name: | Plus Medical Cover Gown |
| Classification | Gown, Surgical |
| Applicant | Foshan Nanhai Plus Medical CO LTD Shatou Jiujiang Town, Nanhai District, Foshan, Foshan, CN 528200 |
| Contact | Eric Li |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Services Co.,Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, CN 510006 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-28 |
| Decision Date | 2022-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973062321431 | K213177 | 000 |
| 30197344039597 | K213177 | 000 |
| 16973062321363 | K213177 | 000 |
| 16973062321370 | K213177 | 000 |
| 16973062321387 | K213177 | 000 |
| 16973062321394 | K213177 | 000 |
| 16973062321400 | K213177 | 000 |
| 16973062321417 | K213177 | 000 |
| 16973062321424 | K213177 | 000 |
| 30197344039580 | K213177 | 000 |