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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 K193516
Device Name Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
Applicant
Gynesonics, Inc.
600 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact Diane King
Correspondent
Gynesonics, Inc.
600 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact Diane King
Regulation Number884.4160
Classification Product Code
KNF  
Subsequent Product Codes
ITX   IYO  
Date Received12/19/2019
Decision Date 05/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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