The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Embryon Transfer Catheters/sets.
| Device ID | K994327 |
| 510k Number | K994327 |
| Device Name: | EMBRYON TRANSFER CATHETERS/SETS |
| Classification | Catheter, Assisted Reproduction |
| Applicant | ROCKET MEDICAL PLC TYNE & WEAR Washington, GB Ne37 1ne |
| Contact | Les Todd |
| Correspondent | Les Todd ROCKET MEDICAL PLC TYNE & WEAR Washington, GB Ne37 1ne |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270967244 | K994327 | 000 |
| 05055270935922 | K994327 | 000 |
| 05055270935915 | K994327 | 000 |
| 05055270957023 | K994327 | 000 |
| 05055270935618 | K994327 | 000 |
| 05055270935601 | K994327 | 000 |
| 05055270956972 | K994327 | 000 |
| 05055270956965 | K994327 | 000 |
| 05055270956958 | K994327 | 000 |
| 05055270935540 | K994327 | 000 |
| 05055270935519 | K994327 | 000 |
| 05055270935458 | K994327 | 000 |
| 05055270957337 | K994327 | 000 |
| 05055270935946 | K994327 | 000 |
| 05055270967213 | K994327 | 000 |
| 05055270936042 | K994327 | 000 |
| 05055270957436 | K994327 | 000 |
| 05055270957429 | K994327 | 000 |
| 05055270936011 | K994327 | 000 |
| 05055270936004 | K994327 | 000 |
| 05055270957399 | K994327 | 000 |
| 05055270957382 | K994327 | 000 |
| 05055270935977 | K994327 | 000 |
| 05055270935960 | K994327 | 000 |
| 05055270935953 | K994327 | 000 |
| 05055270956842 | K994327 | 000 |