K083012 is an FDA 510(k) clearance for the PAPCONE, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Otto Bock Pur Life Science GmbH (Duderstadt, Lower Saxony, DE). The FDA issued a Cleared decision on April 9, 2009, 182 days after receiving the submission on October 9, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K083012 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 09, 2008 |
| Decision Date | April 09, 2009 |
| Days to Decision | 182 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 |