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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 K241140
Device Name ViroZap Indoor Air Purifier, In Duct Model 1008
Applicant
Applied Photonix, LLC
3802 Spectrum Blvd.
Suite 202-1
Tampa,  FL  33612
Applicant Contact D. Yogi Goswami
Correspondent
King & Spalding LLP
1700 Pennsylvania Avenue, NW
Suite 900
Washington,  DC  20006
Correspondent Contact Jeffrey Shapiro
Regulation Number880.6500
Classification Product Code
FRA  
Date Received04/24/2024
Decision Date 08/01/2024
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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