K971586 is an FDA 510(k) clearance for the DIGENE CERVICAL BRUSH, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Digene Corp. (Beltsville, US). The FDA issued a Cleared decision on September 19, 1997, 141 days after receiving the submission on May 1, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K971586 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 1997 |
| Decision Date | September 19, 1997 |
| Days to Decision | 141 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 |