The following data is part of a premarket notification filed by Excellent Medical Technology Group Co., Ltd. with the FDA for Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-sterile.
| Device ID | K220665 |
| 510k Number | K220665 |
| Device Name: | Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile |
| Classification | Gown, Surgical |
| Applicant | Excellent Medical Technology Group Co., Ltd. Room# 2301, Decheng Jiayuan Plaza, No. 1539 Xiangcheng Road Suzhou, CN 215131 |
| Contact | Kenney Song |
| 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 | 2022-03-07 |
| Decision Date | 2022-06-03 |