The following data is part of a premarket notification filed by Weihai Dishang Medical Technology Co., Ltd with the FDA for Surgical Gown, Model: Surgical Gown-hp-3.
| Device ID | K210355 |
| 510k Number | K210355 |
| Device Name: | Surgical Gown, Model: Surgical Gown-hp-3 |
| Classification | Gown, Surgical |
| Applicant | Weihai Dishang Medical Technology Co., Ltd Room 406-409, Block C, No.213 Torch Road, Torch High-tech Industrial Development Zone Weihai, CN 264209 |
| Contact | Ricky Xia |
| Correspondent | Ricky Xia Weihai Dishang Medical Technology Co., Ltd Room 406-409, Block C, No.213 Torch Road, Torch High-tech Industrial Development Zone Weihai, CN 264209 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2021-12-16 |