DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A

Cleaner, Air, Medical Recirculating

HMI INDUSTRIES, INC.

The following data is part of a premarket notification filed by Hmi Industries, Inc. with the FDA for Defender Room Air Cleaner, Model Rac-3000a.

Pre-market Notification Details

Device IDK002692
510k NumberK002692
Device Name:DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
ClassificationCleaner, Air, Medical Recirculating
Applicant HMI INDUSTRIES, INC. 13325 DARICE PKWY. Strongville,  OH  44149
ContactJacqueline A Purcell
CorrespondentJacqueline A Purcell
HMI INDUSTRIES, INC. 13325 DARICE PKWY. Strongville,  OH  44149
Product CodeFRF  
CFR Regulation Number880.5045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-29
Decision Date2000-11-17

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