The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Cardiotomy Reservoir Brs-xxx & Holder Brs-hxx.
| Device ID | K851004 |
| 510k Number | K851004 |
| Device Name: | CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Wendell V Ebling |
| Correspondent | Wendell V Ebling GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-12 |
| Decision Date | 1985-05-16 |