The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Craft Duo-vac Suction Unit, Craft Suction Unit.
| Device ID | K972867 |
| 510k Number | K972867 |
| Device Name: | CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT |
| Classification | Aniline |
| Applicant | ROCKET MEDICAL PLC FACTORIES 3 & 4, WEAR INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne37 1ne |
| Contact | L Todd |
| Correspondent | L Todd ROCKET MEDICAL PLC FACTORIES 3 & 4, WEAR INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne37 1ne |
| Product Code | ICX |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-04 |
| Decision Date | 1997-10-24 |
| Summary: | summary |