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Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)

Ujenzi Charitable Trust · Class II · Cleared Oct 30, 2019

K-numberK191264
Device nameEvery Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
ApplicantUjenzi Charitable Trust
Product codeOQY
Device classClass II
Decision dateOct 30, 2019
DecisionSubstantially Equivalent
Regulation884.4530
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View the full FDA submission: accessdata.fda.gov

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