CLOSED CHEST DRAINAGE SET

General Surgery Tray

GISH BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Closed Chest Drainage Set.

Pre-market Notification Details

Device IDK871873
510k NumberK871873
Device Name:CLOSED CHEST DRAINAGE SET
ClassificationGeneral Surgery Tray
Applicant GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana,  CA  92705
ContactJeanne Pierson
CorrespondentJeanne Pierson
GISH BIOMEDICAL, INC. 2350 S. PULLMAN AVE. Santa Ana,  CA  92705
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-13
Decision Date1987-07-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.