The following data is part of a premarket notification filed by Karex Industries Sdn. Bhd. with the FDA for Water Based Personal Lubricant With Flavours.
| Device ID | K150743 |
| 510k Number | K150743 |
| Device Name: | Water Based Personal Lubricant With Flavours |
| Classification | Lubricant, Personal |
| Applicant | KAREX INDUSTRIES SDN. BHD. PTD 7906 & 7907, TAMAN PONTIAN JAYA, BATU 34, JALAN JOHOR Pontian, MY 82000 |
| Contact | Ms. Mary Goh Yin |
| Correspondent | Ms. Mary Goh Yin KAREX INDUSTRIES SDN. BHD. PTD 7906 & 7907, TAMAN PONTIAN JAYA, BATU 34, JALAN JOHOR Pontian, MY 82000 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-23 |
| Decision Date | 2015-11-12 |