HEPA AIR CLEANER

Cleaner, Air, Medical Recirculating

DURACRAFT CORP.

The following data is part of a premarket notification filed by Duracraft Corp. with the FDA for Hepa Air Cleaner.

Pre-market Notification Details

Device IDK940573
510k NumberK940573
Device Name:HEPA AIR CLEANER
ClassificationCleaner, Air, Medical Recirculating
Applicant DURACRAFT CORP. 355 MAIN ST. Whitinsville,  MA  01588
ContactArthur Wong
CorrespondentArthur Wong
DURACRAFT CORP. 355 MAIN ST. Whitinsville,  MA  01588
Product CodeFRF  
CFR Regulation Number880.5045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-08
Decision Date1994-08-25

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