The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Cervineedle Disposable Cartridge Syringe.
| Device ID | K052365 |
| 510k Number | K052365 |
| Device Name: | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE |
| Classification | Set, Anesthesia, Paracervical |
| Applicant | ROCKET MEDICAL PLC WEAR INDUSTRIAL ESTATE WASHINGTON Tyne And Wear, GB Ne38 9bz |
| Contact | Tracy Charlton |
| Correspondent | Tracy Charlton ROCKET MEDICAL PLC WEAR INDUSTRIAL ESTATE WASHINGTON Tyne And Wear, GB Ne38 9bz |
| Product Code | HEE |
| CFR Regulation Number | 884.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-29 |
| Decision Date | 2005-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270957764 | K052365 | 000 |