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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191264
510(k) Type
Traditional
Applicant
Ujenzi Charitable Trust
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/30/2019
Days to Decision
173 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191264
510(k) Type
Traditional
Applicant
Ujenzi Charitable Trust
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/30/2019
Days to Decision
173 days
Submission Type
Summary