56 SERIES AEROSOL GENERATOR

Nebulizer (direct Patient Interface)

PROJECT MARKETING

The following data is part of a premarket notification filed by Project Marketing with the FDA for 56 Series Aerosol Generator.

Pre-market Notification Details

Device IDK980074
510k NumberK980074
Device Name:56 SERIES AEROSOL GENERATOR
ClassificationNebulizer (direct Patient Interface)
Applicant PROJECT MARKETING 112 CAVISTON WAY Cary,  NC  27560
ContactTerry O'brien
CorrespondentTerry O'brien
PROJECT MARKETING 112 CAVISTON WAY Cary,  NC  27560
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-08
Decision Date1998-06-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.