The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Hystalog Hsg Catheter.
| Device ID | K000340 |
| 510k Number | K000340 |
| Device Name: | HYSTALOG HSG CATHETER |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Applicant | ROCKET MEDICAL PLC WEAR IND. ESTATE DISTRICT 6 Washington, Tyne & Wear, GB Ne37 1ne |
| Contact | L. Todd |
| Correspondent | L. Todd ROCKET MEDICAL PLC WEAR IND. ESTATE DISTRICT 6 Washington, Tyne & Wear, GB Ne37 1ne |
| Product Code | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-03 |
| Decision Date | 2000-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270973528 | K000340 | 000 |
| 05055270935137 | K000340 | 000 |
| 05055270935120 | K000340 | 000 |
| 05055270935113 | K000340 | 000 |
| 05055270935106 | K000340 | 000 |
| 05055270981387 | K000340 | 000 |
| 05055270974457 | K000340 | 000 |
| 05055270966155 | K000340 | 000 |