The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Thorastat Atr-xxxx.
Device ID | K870792 |
510k Number | K870792 |
Device Name: | THORASTAT ATR-XXXX |
Classification | Defoamer, Cardiopulmonary Bypass |
Applicant | GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana, CA 92705 |
Contact | Jeanne Pierson |
Correspondent | Jeanne Pierson 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 | 1987-02-26 |
Decision Date | 1987-04-28 |