AIR SAFETY HEPA AND NON-HEPA FILTERS

Filter, Bacterial, Breathing-circuit

AIR SAFETY LTD

The following data is part of a premarket notification filed by Air Safety Ltd with the FDA for Air Safety Hepa And Non-hepa Filters.

Pre-market Notification Details

Device IDK033008
510k NumberK033008
Device Name:AIR SAFETY HEPA AND NON-HEPA FILTERS
ClassificationFilter, Bacterial, Breathing-circuit
Applicant AIR SAFETY LTD 6329 W. WATERVIEW CT. Mccordsville,  IN  46055 -9501
ContactPaul Dryden
CorrespondentPaul Dryden
AIR SAFETY LTD 6329 W. WATERVIEW CT. Mccordsville,  IN  46055 -9501
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-26
Decision Date2004-05-13
Summary:summary

NIH GUDID Devices

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