The following data is part of a premarket notification filed by Foshan Pingchuang Medical Technology Co., Ltd. with the FDA for Water-soluble Personal Lubricant.
| Device ID | K212104 |
| 510k Number | K212104 |
| Device Name: | Water-soluble Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | Foshan PingChuang Medical Technology Co., Ltd. Room 301, No. 3, Huaye Road, Lingang Pioneer Park, Shunjiang Neighborhood Committee, Beijiao Foshan, CN 528312 |
| Contact | Huang Zhiyue |
| 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 | 2021-07-06 |
| Decision Date | 2021-11-18 |