The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Blood Recovery/autotransfusion Reservoir Atr-2900.
| Device ID | K892443 |
| 510k Number | K892443 |
| Device Name: | BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900 |
| Classification | Apparatus, Autotransfusion |
| Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Contact | Lori Glastetter |
| Correspondent | Lori Glastetter GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-10 |
| Decision Date | 1989-11-08 |