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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intrauterine Tamponade Balloon
510(k) Number K230849
Device Name ELLAVI UBT
Applicant
Sinapi Biomedical (Pty) , Ltd.
1 Lelie Rd.
Stellenbosch,  ZA 7600
Applicant Contact Chris de Villiers
Correspondent
Smith Associates
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact Yolanda R Smith
Regulation Number884.4530
Classification Product Code
OQY  
Date Received03/28/2023
Decision Date 11/13/2023
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
Predetermined Change
Control Plan Authorized		 No
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