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StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200723
510(k) Type
Traditional
Applicant
Medtronic Navigation Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/26/2020
Days to Decision
99 days
Submission Type
Summary

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200723
510(k) Type
Traditional
Applicant
Medtronic Navigation Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/26/2020
Days to Decision
99 days
Submission Type
Summary