DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

DAVOL, INC.

The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Dual Lumen 5 Fr Perip Cent Ven Cath W/groshong Val.

Pre-market Notification Details

Device IDK904558
510k NumberK904558
Device Name:DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant DAVOL, INC. 3385 WEST 1820 Salt Lake City,  UT  84104
ContactJack Speer
CorrespondentJack Speer
DAVOL, INC. 3385 WEST 1820 Salt Lake City,  UT  84104
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-05
Decision Date1991-02-11

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