STERILE WATER FOR INHALATION USP 2D0799

Humidifier, Respiratory Gas, (direct Patient Interface)

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Sterile Water For Inhalation Usp 2d0799.

Pre-market Notification Details

Device IDK851940
510k NumberK851940
Device Name:STERILE WATER FOR INHALATION USP 2D0799
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
ContactDennis A Ocwieja
CorrespondentDennis A Ocwieja
TRAVENOL LABORATORIES, S.A. Deerfield,  IL  60015
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-03
Decision Date1985-06-20

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