The following data is part of a premarket notification filed by Foshan Nanhai Plus Medical Co Ltd with the FDA for Plus Medical Chemotherapy Gown.
| Device ID | K211036 |
| 510k Number | K211036 |
| Device Name: | Plus Medical Chemotherapy Gown |
| Classification | Gown, Surgical |
| Applicant | Foshan Nanhai Plus Medical CO LTD Shatou Jiujiang Town, Nanhai District Foshan, CN 528200 |
| Contact | Eric Li |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Service 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 | 2021-04-07 |
| Decision Date | 2022-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973062321479 | K211036 | 000 |
| 16973062321462 | K211036 | 000 |
| 16973062321455 | K211036 | 000 |
| 16973062321448 | K211036 | 000 |
| 50885380196995 | K211036 | 000 |
| 50885380196971 | K211036 | 000 |
| 50885380196957 | K211036 | 000 |
| 50885380196933 | K211036 | 000 |