K192669 is an FDA 510(k) clearance for the Extremely Thin 003, ZERO ZERO THREE. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Okamoto USA, Inc. (Stratford, US). The FDA issued a Cleared decision on July 24, 2020, 303 days after receiving the submission on September 25, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K192669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2019 |
| Decision Date | July 24, 2020 |
| Days to Decision | 303 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 |