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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 K240782
Device Name CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)
Applicant
Pulse Biosciences, Inc.
3957 Point Eden Way
Hayward,  CA  94545
Applicant Contact Uyen Mai
Correspondent
Pulse Biosciences, Inc.
3957 Point Eden Way
Hayward,  CA  94545
Correspondent Contact Uyen Mai
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/21/2024
Decision Date 08/05/2024
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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