The following data is part of a premarket notification filed by Jostra Bentley with the FDA for Hollow Fiber Membrane Oygenator Quadrox Hmo 1010.
| Device ID | K992559 |
| 510k Number | K992559 |
| Device Name: | HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | JOSTRA BENTLEY 2035 SUNSET LAKE RD. Newark, DE 19702 |
| Contact | Kathy Johnson |
| Correspondent | Kathy Johnson JOSTRA BENTLEY 2035 SUNSET LAKE RD. Newark, DE 19702 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-30 |
| Decision Date | 1999-09-20 |
| Summary: | summary |