The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Rocket Pleuraseal Ii Chest Drainage System.
| Device ID | K961287 |
| 510k Number | K961287 |
| Device Name: | ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM |
| Classification | Bottle, Collection, Vacuum |
| Applicant | ROCKET MEDICAL PLC FACTORIES 3 & 4, WEAR INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne37 1ne |
| Contact | L Todd |
| Correspondent | L Todd ROCKET MEDICAL PLC FACTORIES 3 & 4, WEAR INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne37 1ne |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-03 |
| Decision Date | 1996-07-26 |
| Summary: | summary |