The following data is part of a premarket notification filed by Boya Biotechnology Co., Ltd. with the FDA for Lubi Water Based Personal Lubricant.
| Device ID | K203257 |
| 510k Number | K203257 |
| Device Name: | LUBi Water Based Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | Boya Biotechnology Co., Ltd. Floor3,#7, Changfu Rd., Ludong Community, Humen Town Dongguan, CN 523935 |
| Contact | Jason Lau |
| Correspondent | Joyce Yang Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, CN 518100 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-04 |
| Decision Date | 2020-12-23 |