The following data is part of a premarket notification filed by Qingdao Youjia Hygiene Technology Co., Ltd with the FDA for Youjia Unscented Tampon With Plastic Applicators.
| Device ID | K192557 |
| 510k Number | K192557 |
| Device Name: | Youjia Unscented Tampon With Plastic Applicators |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Qingdao Youjia Hygiene Technology Co., Ltd No. 778 Mingyue Road, Huangdao Zone Qingdao, CN 266400 |
| Contact | Huiying Zhao |
| Correspondent | Emma Xing Suzhou Jiuzhen Consulting Company Ltd. North Building, A1, 218, Xinghu Str., Suzhou Industrial Park Suzhou, CN 215123 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B845TPVPEBS21 | K192557 | 000 |
| B845TPVPEBR23 | K192557 | 000 |