The following data is part of a premarket notification filed by Xiantao Rayxin Medical Products Co., Ltd. with the FDA for Disposable Ultra Reinforced Surgical Gown.
| Device ID | K173847 |
| 510k Number | K173847 |
| Device Name: | Disposable Ultra Reinforced Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Xiantao Rayxin Medical Products Co., Ltd. No. 258 Pengchang Road, Middle Street Xiantao, CN 433018 |
| Contact | Liang Zhang |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-19 |
| Decision Date | 2019-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812460028114 | K173847 | 000 |
| 10812460028107 | K173847 | 000 |
| 10812460028091 | K173847 | 000 |
| 06971604530276 | K173847 | 000 |
| 06971604530283 | K173847 | 000 |
| 16971604530013 | K173847 | 000 |
| 06971604530306 | K173847 | 000 |