The following data is part of a premarket notification filed by Xiantao Rayxin Medical Products Co., Ltd. with the FDA for Disposable Surgical Face Mask.
| Device ID | K153496 |
| 510k Number | K153496 |
| Device Name: | Disposable Surgical Face Mask |
| Classification | Mask, 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 Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd. Chaoyang District Beijing, CN 100024 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-07 |
| Decision Date | 2016-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60665973010375 | K153496 | 000 |