K884401 is an FDA 510(k) clearance for the SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT. 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 January 12, 1989, 85 days after receiving the submission on October 19, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K884401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1988 |
| Decision Date | January 12, 1989 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HIS — Condom |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5300 |