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 |