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 |