The following data is part of a premarket notification filed by Karex Industries Sdn Bhd with the FDA for Orange Colored Condoms Orange Scent.
| Device ID | K113056 |
| 510k Number | K113056 |
| Device Name: | ORANGE COLORED CONDOMS ORANGE SCENT |
| Classification | Condom |
| Applicant | KAREX INDUSTRIES SDN BHD PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR Pontian, Johor, MY 82000 |
| Contact | Lai Peng Lim |
| Correspondent | Lai Peng Lim KAREX INDUSTRIES SDN BHD PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR Pontian, Johor, MY 82000 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-14 |
| Decision Date | 2012-07-03 |