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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 K222702
Device Name RGS; RGS Mini
Applicant
Genesis Air, Inc.
5202 County Rd. 7350, Suite D
Lubbock,  TX  79424
Applicant Contact Dan Briggs
Correspondent
Sterling Medical Devices
250 Moonachie Rd., Suite 400
Moonachie,  NJ  07074
Correspondent Contact Carrie Hetrick
Regulation Number880.6500
Classification Product Code
FRA  
Date Received09/07/2022
Decision Date 06/02/2023
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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