K900908 is an FDA 510(k) clearance for the CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200. This device is classified as a Insufflator, Hysteroscopic (Class II - Special Controls, product code HIG).
Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on May 21, 1990, 83 days after receiving the submission on February 27, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1700.
| 510(k) Number | K900908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1990 |
| Decision Date | May 21, 1990 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HIG — Insufflator, Hysteroscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1700 |