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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Energy Direct Current Thermal Ablation System
510(k) Number K233884
Device Name INUMI™ Flex Needle
Applicant
Galvanize Therapeutics, Inc.
3200 Bridge Pkwy.
Redwood City,  CA  94065
Applicant Contact Deborah Sheffield
Correspondent
Galvanize Therapeutics, Inc.
3200 Bridge Pkwy.
Redwood City,  CA  94065
Correspondent Contact Dongbo Wang
Regulation Number878.4400
Classification Product Code
OAB  
Subsequent Product Code
GEI  
Date Received12/08/2023
Decision Date 05/22/2024
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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