ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

Catheter, Retention Type, Balloon

FORTUNE MEDICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by Fortune Medical Instrument Corp. with the FDA for All Silicone 2-way & 3-way Foly Balloon Catheter And Nelaton Catheter.

Pre-market Notification Details

Device IDK980919
510k NumberK980919
Device Name:ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
ClassificationCatheter, Retention Type, Balloon
Applicant FORTUNE MEDICAL INSTRUMENT CORP. 3722 AVE. SAUSALITO Irvine,  CA  92606
ContactKaren U Salinas
CorrespondentKaren U Salinas
FORTUNE MEDICAL INSTRUMENT CORP. 3722 AVE. SAUSALITO Irvine,  CA  92606
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-11
Decision Date1998-03-31

NIH GUDID Devices

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