The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Ibc Flopump With Gbs Coating.
| Device ID | K031300 |
| 510k Number | K031300 |
| Device Name: | IBC FLOPUMP WITH GBS COATING |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-24 |
| Decision Date | 2003-05-14 |
| Summary: | summary |