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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tenaculum, Uterine
510(k) Number K203820
Device Name ASPIVIX v1.1 Cervical Suction Tenaculum
Applicant
Aspivix S.A.
Chemin du Closel
Renens,  CH 1020
Applicant Contact Benjamin Klein
Correspondent
Aspivix S.A.
Chemin du Closel 5
Renens,  CH 1020
Correspondent Contact Julien Finci
Regulation Number884.4530
Classification Product Code
HDC  
Date Received12/29/2020
Decision Date 08/17/2021
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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