The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Embryon Single And Double Lumen Needles.
| Device ID | K000205 |
| 510k Number | K000205 |
| Device Name: | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES |
| Classification | Needle, Assisted Reproduction |
| Applicant | ROCKET MEDICAL PLC WARE INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne37 1ne |
| Contact | Les Todd |
| Correspondent | Les Todd ROCKET MEDICAL PLC WARE INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne37 1ne |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-21 |
| Decision Date | 2000-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270973504 | K000205 | 000 |
| 05055270935731 | K000205 | 000 |
| 05055270935724 | K000205 | 000 |
| 05055270935717 | K000205 | 000 |
| 05055270935700 | K000205 | 000 |
| 05055270957078 | K000205 | 000 |
| 05055270935663 | K000205 | 000 |
| 05055270957054 | K000205 | 000 |
| 05055270978868 | K000205 | 000 |
| 05055270957146 | K000205 | 000 |
| 05055270935779 | K000205 | 000 |
| 05055270972552 | K000205 | 000 |
| 05055270965226 | K000205 | 000 |
| 05055270963956 | K000205 | 000 |
| 05055270936165 | K000205 | 000 |
| 05055270957221 | K000205 | 000 |
| 05055270957214 | K000205 | 000 |
| 05055270935793 | K000205 | 000 |
| 05055270957184 | K000205 | 000 |
| 05055270957245 | K000205 | 000 |