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Uterine ElevatOR PRO with OccludOR Balloon

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220202
510(k) Type
Traditional
Applicant
The O R Company Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
3/31/2022
Days to Decision
66 days
Submission Type
Summary

Uterine ElevatOR PRO with OccludOR Balloon

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220202
510(k) Type
Traditional
Applicant
The O R Company Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
3/31/2022
Days to Decision
66 days
Submission Type
Summary