K935665 is an FDA 510(k) clearance for the INTRAUTERINE SOUND. This device is classified as a Sound, Uterine (Class I — General Controls, product code HHM).
Submitted by Rocket of London, Ltd. (Tyne & Wear, GB). The FDA issued a Cleared decision on February 24, 1994, 90 days after receiving the submission on November 26, 1993.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K935665 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 26, 1993 |
| Decision Date | February 24, 1994 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHM — Sound, Uterine |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 884.4530 |