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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K232645
Device Name Airgle Room Air Purifier
Applicant
Airgle Corporation
1170 Lincoln Avenue Unit 2
Holbrook,  NY  11741
Applicant Contact Jerry Liu
Correspondent
Airgle Corporation
1170 Lincoln Avenue Unit 2
Holbrook,  NY  11741
Correspondent Contact Jet Li
Regulation Number880.6500
Classification Product Code
FRA  
Date Received08/30/2023
Decision Date 02/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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