The following data is part of a premarket notification filed by Jostra Ag with the FDA for Jostra Mecc System.
| Device ID | K023132 |
| 510k Number | K023132 |
| Device Name: | JOSTRA MECC SYSTEM |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | JOSTRA AG 2828 N. CRESCENT RIDGE DR. The Woodlands, TX 77381 |
| Contact | Kathleen Johnson |
| Correspondent | Kathleen Johnson JOSTRA AG 2828 N. CRESCENT RIDGE DR. The Woodlands, TX 77381 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-20 |
| Decision Date | 2002-12-17 |
| Summary: | summary |