The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Gish Reliance Oxygenator (model Hfo).
| Device ID | K961530 |
| 510k Number | K961530 |
| Device Name: | GISH RELIANCE OXYGENATOR (MODEL HFO) |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Contact | Jack W Brown |
| Correspondent | Jack W Brown GISH BIOMEDICAL, INC. 2681 KELVIN AVE. Irvine, CA 92614 -5821 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-22 |
| Decision Date | 1996-12-05 |
| Summary: | summary |