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FDA 510(k) Application Details - K222702
Device Classification Name
Purifier, Air, Ultraviolet, Medical
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510(K) Number
K222702
Device Name
Purifier, Air, Ultraviolet, Medical
Applicant
Genesis Air, Inc.
5202 County Road 7350, Suite D
Lubbock, TX 79424 US
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Contact
Dan Briggs
Other 510(k) Applications for this Contact
Regulation Number
880.6500
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Classification Product Code
FRA
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More FDA Info for this Product Code
Date Received
09/07/2022
Decision Date
06/02/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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