The following data is part of a premarket notification filed by Xiantao Zhibo Non-woven Products Co., Ltd with the FDA for Surgical Face Mask.
| Device ID | K182514 |
| 510k Number | K182514 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Xiantao Zhibo Non-woven Products Co., Ltd NO.8 In Industrial Park, Hefeng Road Xiantao, CN 430000 |
| Contact | Yao Sanyu |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 4th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2019-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850017230026 | K182514 | 000 |
| 00723896016138 | K182514 | 000 |
| 30850015055011 | K182514 | 000 |
| 06973244780004 | K182514 | 000 |