K011481 is an FDA 510(k) clearance for the 10% PVP. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Conception Technologies (Irvine, US). The FDA issued a Cleared decision on July 2, 2001, 49 days after receiving the submission on May 14, 2001.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K011481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2001 |
| Decision Date | July 02, 2001 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |