The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack And Bottle Set, Rocket Ipc Drainage B.
| Device ID | K123033 |
| 510k Number | K123033 |
| Device Name: | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | ROCKET MEDICAL PLC FACTORIES 2& 4, SEDLING RD WEAR INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne38 9bz |
| Contact | Tracy Charlton |
| Correspondent | Tracy Charlton ROCKET MEDICAL PLC FACTORIES 2& 4, SEDLING RD WEAR INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne38 9bz |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2013-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270973443 | K123033 | 000 |
| 05055270921420 | K123033 | 000 |
| 05055270942838 | K123033 | 000 |
| 05055270942845 | K123033 | 000 |
| 05055270921451 | K123033 | 000 |
| 05055270963680 | K123033 | 000 |
| 05055270965745 | K123033 | 000 |
| 05055270965776 | K123033 | 000 |
| 05055270965837 | K123033 | 000 |
| 05055270965868 | K123033 | 000 |
| 05055270965899 | K123033 | 000 |
| 05055270965929 | K123033 | 000 |
| 05055270968050 | K123033 | 000 |
| 05055270971234 | K123033 | 000 |
| 05055270971654 | K123033 | 000 |
| 05055270972460 | K123033 | 000 |
| 05055270973382 | K123033 | 000 |
| 05055270982346 | K123033 | 000 |