The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Closed Chest Drainage Set W/sutures.
| Device ID | K873377 |
| 510k Number | K873377 |
| Device Name: | CLOSED CHEST DRAINAGE SET W/SUTURES |
| Classification | Catheter, Ventricular, General & Plastic Surgery |
| 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 | GBS |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-24 |
| Decision Date | 1987-10-28 |