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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K231146
Device Name AliTight
Applicant
Alic Iotech, LLC
8165 Mountain View Dr. Unit D
Pleasanton,  CA  94588
Applicant Contact Like Zeng
Correspondent
Alic Iotech, LLC
8165 Mountain View Dr. Unit D
Pleasanton,  CA  94588
Correspondent Contact Like Zeng
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/21/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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