K140379 is an FDA 510(k) clearance for the MEGA BIG BOY CONDOM. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Okamoto USA, Inc. (Washington, US). The FDA issued a Cleared decision on July 1, 2014, 137 days after receiving the submission on February 14, 2014.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K140379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2014 |
| Decision Date | July 01, 2014 |
| Days to Decision | 137 days |
| Submission Type | Abbreviated |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIS - Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |