K983181 is an FDA 510(k) clearance for the CYTOPREP, a System, Abortion, Vacuum (Class II — Special Controls, product code HHI), submitted by Cytoprep Inc. Est. (Eschen, LI). The FDA issued a Cleared decision on November 16, 1998, 66 days after receiving the submission on September 11, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.
| 510(k) Number | K983181 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 1998 |
| Decision Date | November 16, 1998 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHI — System, Abortion, Vacuum |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5070 |