The following data is part of a premarket notification filed by Wettrust Korea Co., Ltd. with the FDA for Wettrust D2care.
| Device ID | K170797 |
| 510k Number | K170797 |
| Device Name: | Wettrust D2care |
| Classification | Lubricant, Personal |
| Applicant | Wettrust Korea Co., Ltd. 312 The Prau, 27 Jeongjail-ro, Bundang-gu Seongnam, KR 463-480 |
| Contact | Sungho Lee |
| Correspondent | Jigar Shah mdi Consultant, Inc. 55 Northern Blvd Great Neck, NY 11021 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-17 |
| Decision Date | 2017-12-06 |
| Summary: | summary |