CONDENSATE COLLECTION KIT

Circuit, Breathing (w Connector, Adaptor, Y Piece)

NOVA-VENTRX

The following data is part of a premarket notification filed by Nova-ventrx with the FDA for Condensate Collection Kit.

Pre-market Notification Details

Device IDK954480
510k NumberK954480
Device Name:CONDENSATE COLLECTION KIT
ClassificationCircuit, Breathing (w Connector, Adaptor, Y Piece)
Applicant NOVA-VENTRX 1974 RAYMOND DR. Northbrook,  IL  60062
ContactBernard R Paluch
CorrespondentBernard R Paluch
NOVA-VENTRX 1974 RAYMOND DR. Northbrook,  IL  60062
Product CodeCAI  
CFR Regulation Number868.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-26
Decision Date1995-12-29

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