The following data is part of a premarket notification filed by Qingdao Youjia Hygiene Technology Co., Ltd with the FDA for Unscented Menstrual Tampon.
| Device ID | K190218 |
| 510k Number | K190218 |
| Device Name: | Unscented Menstrual Tampon |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Qingdao Youjia Hygiene Technology Co., Ltd No. 778 Mingyue Road, Huangdao Zone Qingdao, CN 266400 |
| Contact | Huiying Zhao |
| Correspondent | Jessie You Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, CN Gd755 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B845TPVPEBR23 | K190218 | 000 |
| B845TPVPEBS21 | K190218 | 000 |