K896960 is an FDA 510(k) clearance for the INTRAUTERINE INSEMINATION CATHETERS. This device is classified as a Cap, Cervical (Class II - Special Controls, product code HDR).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on June 26, 1990, 194 days after receiving the submission on December 14, 1989.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5250.
| 510(k) Number | K896960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1989 |
| Decision Date | June 26, 1990 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HDR — Cap, Cervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5250 |