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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 K211444
Device Name CellFX System
Applicant
Pulse Biosciences, Inc.
3957 Point Eden Way
Hayward,  CA  94545
Applicant Contact Punam Gollamudi
Correspondent
Pulse Biosciences, Inc.
3957 Point Eden Way
Hayward,  CA  94545
Correspondent Contact Punam Gollamudi
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/10/2021
Decision Date 08/25/2021
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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