The following data is part of a premarket notification filed by Karex Industries Sdn Bhd. with the FDA for Large/extra Lagre Condom.
| Device ID | K113061 |
| 510k Number | K113061 |
| Device Name: | LARGE/EXTRA LAGRE CONDOM |
| Classification | Condom |
| Applicant | KAREX INDUSTRIES SDN BHD. PTD. 7906 & 7907, TAMAN PONTIAN JAYA, BT 34 Johor Darul Takzim, MY 82000 |
| Contact | Lai Peng |
| Correspondent | Lai Peng KAREX INDUSTRIES SDN BHD. PTD. 7906 & 7907, TAMAN PONTIAN JAYA, BT 34 Johor Darul Takzim, 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 | 2011-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20302340300456 | K113061 | 000 |
| 00850002174847 | K113061 | 000 |
| 00850002174359 | K113061 | 000 |
| 00850002174342 | K113061 | 000 |
| 00023403005502 | K113061 | 000 |
| 40302340300559 | K113061 | 000 |
| 77302340300454 | K113061 | 000 |