K090259 is an FDA 510(k) clearance for the OKAMOTO ULTRA THIN, a Condom (Class II — Special Controls, product code HIS), submitted by Okamoto USA, Inc. (Washington, US). The FDA issued a Cleared decision on March 31, 2009, 57 days after receiving the submission on February 2, 2009. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K090259 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 02, 2009 |
| Decision Date | March 31, 2009 |
| Days to Decision | 57 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 |