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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 K212871
Device Name Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
Applicant
Galvanize Therapeutics, Inc.
1531 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact Deborah Sheffield
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolois,  MN  55402
Correspondent Contact Lisa L. Pritchard
Regulation Number878.4400
Classification Product Code
OAB  
Date Received09/09/2021
Decision Date 06/17/2022
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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