The following data is part of a premarket notification filed by Suzhou Borage Medical Technology Co., Ltd. with the FDA for Unscented Menstrual Tampon.
| Device ID | K222046 |
| 510k Number | K222046 |
| Device Name: | Unscented Menstrual Tampon |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Suzhou Borage Medical Technology Co., Ltd. No.9, Shiheshan Road, Dongshan Town, Wuzhong District Suzhou, CN 215107 |
| Contact | Zhou Nana |
| Correspondent | Grace Liu Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, CN 518000 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-11 |
| Decision Date | 2022-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840117328440 | K222046 | 000 |
| 08401173284198 | K222046 | 000 |
| 00840117328471 | K222046 | 000 |
| 08401173287854 | K222046 | 000 |