SMALL VOLUME NEBULIZER

Nebulizer (direct Patient Interface)

ALLEGIANCE HEALTHCARE CORPORATION

The following data is part of a premarket notification filed by Allegiance Healthcare Corporation with the FDA for Small Volume Nebulizer.

Pre-market Notification Details

Device IDK023602
510k NumberK023602
Device Name:SMALL VOLUME NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant ALLEGIANCE HEALTHCARE CORPORATION 1500 WAUKEGAN RD., BLDG. WM Mcgaw Park,  IL  60085
ContactSharon Nichols
CorrespondentSharon Nichols
ALLEGIANCE HEALTHCARE CORPORATION 1500 WAUKEGAN RD., BLDG. WM Mcgaw Park,  IL  60085
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-28
Decision Date2003-05-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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30889483571174 K023602 000
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30889483583351 K023602 000

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