K895251 is an FDA 510(k) clearance for the BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)). This device is classified as a Alarm, Conditioned Response Enuresis (Class II - Special Controls, product code KPN).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on November 13, 1989, 84 days after receiving the submission on August 21, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.2040.
| 510(k) Number | K895251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1989 |
| Decision Date | November 13, 1989 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KPN — Alarm, Conditioned Response Enuresis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.2040 |