The following data is part of a premarket notification filed by Shenzhen Huanqiu Xuebao Technology Co., Ltd. with the FDA for Personal Lubricant.
| Device ID | K210857 |
| 510k Number | K210857 |
| Device Name: | Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | Shenzhen Huanqiu Xuebao Technology Co., Ltd. Room 303, Building 2, Lane 2, Jinjuxia Road, Bao'an Avenue Fuyong Street Bao'an District Shenzhen, CN 518100 |
| Contact | Jiao Li |
| Correspondent | Kevin Zhang Wenzhou ThiWe Business Consulting Co., Ltd. Room 1203, Building C, Hua'ou Jiayuan, No. 50 Tangjiaqiao South Road Longwan District, Wenzhou, CN 325000 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-23 |
| Decision Date | 2021-09-24 |