The following data is part of a premarket notification filed by Jostra Bentley with the FDA for Jostra Hl-20 Twin Pump.
| Device ID | K984338 |
| 510k Number | K984338 |
| Device Name: | JOSTRA HL-20 TWIN PUMP |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | JOSTRA BENTLEY 478 MEDIA RD. Oxford, PA 19363 |
| Contact | Kathy Johnson |
| Correspondent | Kathy Johnson JOSTRA BENTLEY 478 MEDIA RD. Oxford, PA 19363 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-03 |
| Decision Date | 1999-08-19 |
| Summary: | summary |