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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K253355
Device Name Difiney Advanced Anti Snoring Device 4.0
Applicant
Fissiontech, LLC
1 Liberty St., Floor 3
New York,  NY  10006
Applicant Contact Mike Lee
Correspondent
Shanghai Spica Management Consulting Co., Ltd.
609 Rm., #133 Shengang Ave.
Pudong New District
Shanghai,  CN 200120
Correspondent Contact Purity Chen
Regulation Number872.5570
Classification Product Code
LRK  
Date Received09/30/2025
Decision Date 10/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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