The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Embryon Gift Transfer Catheters/sets.
| Device ID | K000656 |
| 510k Number | K000656 |
| Device Name: | EMBRYON GIFT TRANSFER CATHETERS/SETS |
| Classification | Catheter, 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 | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-03-09 |