K852620 is an FDA 510(k) clearance for the SAFE.N.SURE. This device is classified as a Condom (Class II - Special Controls, product code HIS).
Submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on October 31, 1985, 133 days after receiving the submission on June 20, 1985.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.
| 510(k) Number | K852620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 1985 |
| Decision Date | October 31, 1985 |
| Days to Decision | 133 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 |