The following data is part of a premarket notification filed by Beijing Biosis Healing Biological Technology Co., Ltd with the FDA for Medical Surgical Gowns.
| Device ID | K202844 |
| 510k Number | K202844 |
| Device Name: | Medical Surgical Gowns |
| Classification | Gown, Surgical |
| Applicant | Beijing Biosis Healing Biological Technology Co., Ltd No.6 Plant West, Valley No.1 Bio-medicine Industry Park, Daxing District, Beijing, CN 102600 |
| Contact | Ting Jiang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2021-01-06 |