K000394 is an FDA 510(k) clearance for the CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT. This device is classified as a Accessory, Assisted Reproduction (Class II - Special Controls, product code MQG).
Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on February 29, 2000, 22 days after receiving the submission on February 7, 2000.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6120.
| 510(k) Number | K000394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2000 |
| Decision Date | February 29, 2000 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQG - Accessory, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6120 |