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StealthStation System with Cranial Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153660
510(k) Type
Traditional
Applicant
MEDTRONIC NAVIGATION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/14/2016
Days to Decision
268 days
Submission Type
Summary

StealthStation System with Cranial Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153660
510(k) Type
Traditional
Applicant
MEDTRONIC NAVIGATION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/14/2016
Days to Decision
268 days
Submission Type
Summary