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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K191958
Device Name Aveta System
Applicant
Meditrina, Inc.
1190 Saratoga Avenue, Suite 180
San Jose,  CA  95129
Applicant Contact Csaba Truckai
Correspondent
Meditrina, Inc.
1190 Saratoga Avenue, Suite 180
San Jose,  CA  95129
Correspondent Contact Csaba Truckai
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
HIG  
Date Received07/23/2019
Decision Date 10/01/2019
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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