The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Craft Duo-vac Suction Unit And Craft Suction Unit.
| Device ID | K000394 |
| 510k Number | K000394 |
| Device Name: | CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT |
| Classification | Accessory, Assisted Reproduction |
| Applicant | ROCKET MEDICAL PLC WEAR IND. ESTATE DISTRICT 6 Washington, Tyne & Wear, GB Ne37 1ne |
| Contact | Les Todd |
| Correspondent | Les Todd ROCKET MEDICAL PLC WEAR IND. ESTATE DISTRICT 6 Washington, Tyne & Wear, GB Ne37 1ne |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-02-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270911636 | K000394 | 000 |
| 05055270911629 | K000394 | 000 |
| 05055270911582 | K000394 | 000 |
| 05055270984463 | K000394 | 000 |
| 05055270909329 | K000394 | 000 |
| 05055270909060 | K000394 | 000 |
| 05055270984524 | K000394 | 000 |