K972867 is an FDA 510(k) clearance for the CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT. This device is classified as a Aniline (Class I - General Controls, product code ICX).
Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on October 24, 1997, 81 days after receiving the submission on August 4, 1997.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K972867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1997 |
| Decision Date | October 24, 1997 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | ICX — Aniline |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |