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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K211535
Device Name Sonata Transcervical Fibroid Ablation System 2.2
Applicant
Gynesonics, Inc.
600 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact Christine Ehmann
Correspondent
Gynesonics, Inc.
600 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact Christine Ehmann
Regulation Number884.4160
Classification Product Code
KNF  
Subsequent Product Codes
ITX   IYO  
Date Received05/18/2021
Decision Date 06/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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