K950780 is an FDA 510(k) clearance for the AMSINO CERVICAL SCRAPER. This device is classified as a Spatula, Cervical, Cytological (Class II - Special Controls, product code HHT).
Submitted by Amsino Intl., Inc. (City Of Industry, US). The FDA issued a Cleared decision on July 25, 1995, 154 days after receiving the submission on February 21, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K950780 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1995 |
| Decision Date | July 25, 1995 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HHT — Spatula, Cervical, Cytological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |