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Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182006
510(k) Type
Special
Applicant
Hologic, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/6/2018
Days to Decision
132 days
Submission Type
Summary

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182006
510(k) Type
Special
Applicant
Hologic, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/6/2018
Days to Decision
132 days
Submission Type
Summary