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FDA 510(k) Application Details - K002692
Device Classification Name
Cleaner, Air, Medical Recirculating
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510(K) Number
K002692
Device Name
Cleaner, Air, Medical Recirculating
Applicant
HMI INDUSTRIES, INC.
13325 DARICE PKWY.
STRONGVILLE, OH 44149 US
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Contact
JACQUELINE A PURCELL
Other 510(k) Applications for this Contact
Regulation Number
880.5045
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Classification Product Code
FRF
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More FDA Info for this Product Code
Date Received
08/29/2000
Decision Date
11/17/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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