The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Closed Chest Drainage Set.
Device ID | K871873 |
510k Number | K871873 |
Device Name: | CLOSED CHEST DRAINAGE SET |
Classification | General Surgery Tray |
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 | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-13 |
Decision Date | 1987-07-09 |