The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Ultra-fine Diathermy Loop And Coagulation Balls.
| Device ID | K972856 |
| 510k Number | K972856 |
| Device Name: | ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | ROCKET MEDICAL PLC TYNE & WEAR Washington, GB Ne37 1ne |
| Contact | L. Todd |
| Correspondent | L. Todd ROCKET MEDICAL PLC TYNE & WEAR Washington, GB Ne37 1ne |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-01 |
| Decision Date | 1998-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270957733 | K972856 | 000 |
| 05055270936325 | K972856 | 000 |
| 05055270957689 | K972856 | 000 |
| 05055270936240 | K972856 | 000 |
| 05055270936233 | K972856 | 000 |
| 05055270957610 | K972856 | 000 |
| 05055270936196 | K972856 | 000 |
| 05055270936189 | K972856 | 000 |