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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Accessory Microbial Reduction Device.
510(k) Number K252471
Device Name Paptizer 360
Applicant
LiViliti Health Products Corporation
2140 SW Main Blvd.
Lake City,  FL  32025
Applicant Contact Brian Sharpe
Correspondent
Nilo Medical Consulting Group
3706 Butler St., #313
Pittsburgh,  PA  15201
Correspondent Contact Michael Nilo
Classification Product Code
QXQ  
Date Received08/06/2025
Decision Date 04/29/2026
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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