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 |