The following data is part of a premarket notification filed by Leocor, Inc. with the FDA for Leocor Corflo(tm) Pump.
| Device ID | K900350 |
| 510k Number | K900350 |
| Device Name: | LEOCOR CORFLO(TM) PUMP |
| Classification | Echocardiograph |
| Applicant | LEOCOR, INC. 355 EAST NASA RD.1 Webster, TX 77598 |
| Contact | Snyder, Phd |
| Correspondent | Snyder, Phd LEOCOR, INC. 355 EAST NASA RD.1 Webster, TX 77598 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-24 |
| Decision Date | 1990-07-17 |