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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 K223813
Device Name Aveta System 2.0
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 Codes
FAJ   HIG  
Date Received12/20/2022
Decision Date 08/21/2023
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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