K935820 is an FDA 510(k) clearance for the KOLSTER METHODS. This device is classified as a Cannula, Suction, Uterine (Class II - Special Controls, product code HGH).
Submitted by Kolster Methods (Anaheim, US). The FDA issued a Cleared decision on July 19, 1994, 228 days after receiving the submission on December 3, 1993.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5070.
| 510(k) Number | K935820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1993 |
| Decision Date | July 19, 1994 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HGH — Cannula, Suction, Uterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5070 |