PRODOSE AAD SYSTEM

Nebulizer (direct Patient Interface)

PROFILE THERAPEUTICS PLC

The following data is part of a premarket notification filed by Profile Therapeutics Plc with the FDA for Prodose Aad System.

Pre-market Notification Details

Device IDK030747
510k NumberK030747
Device Name:PRODOSE AAD SYSTEM
ClassificationNebulizer (direct Patient Interface)
Applicant PROFILE THERAPEUTICS PLC 6329 W. WATERVIEW CT. Mccordsville,  IN  46055 -9501
ContactPaul Dryden
CorrespondentPaul Dryden
PROFILE THERAPEUTICS PLC 6329 W. WATERVIEW CT. Mccordsville,  IN  46055 -9501
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-10
Decision Date2004-04-22
Summary:summary

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