K113061 is an FDA 510(k) clearance for the LARGE/EXTRA LAGRE CONDOM. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Karex Industries Sdn. Bhd. (Johor Darul Takzim, MY). The FDA issued a Cleared decision on December 7, 2011, 54 days after receiving the submission on October 14, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K113061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2011 |
| Decision Date | December 07, 2011 |
| Days to Decision | 54 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIS - Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |