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510(k) K223328

Purgo by Aeroclean Technologies, Inc. — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2022
Date Received
October 31, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Air, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6500
Review Panel
HO
Submission Type

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