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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 K190372
Device Name Aveta System
Applicant
Meditrina, Inc.
1601 S. De Anza Blvd, Suite 165
Cupertino,  CA  95014
Applicant Contact Csaba Truckai
Correspondent
Meditrina, Inc.
1601 S. De Anza Blvd, Suite 165
Cupertino,  CA  95014
Correspondent Contact Csaba Truckai
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
HIG  
Date Received02/15/2019
Decision Date 05/16/2019
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
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