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510(k) K010616

DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A by Hmi Industries, Inc. — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2001
Date Received
March 1, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

Other clearances by Hmi Industries, Inc.

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