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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 K191264
Device Name Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
Ujenzi Charitable Trust
22 Welgate Road
medford,  MA  02155
Applicant Contact thomas burke
Hogan Lovells US LLP
555 13th St. NW
washington,  DC  20004
Correspondent Contact jonathan s. kahan
Regulation Number884.4530
Classification Product Code
Date Received05/10/2019
Decision Date 10/30/2019
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