K933415 is an FDA 510(k) clearance for the DETECT (TM) CYTOLOGY BRUSH, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on February 25, 1994, 227 days after receiving the submission on July 13, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K933415 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 1993 |
| Decision Date | February 25, 1994 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHT — Spatula, Cervical, Cytological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |