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StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190672
510(k) Type
Traditional
Applicant
Medtronic Navigation Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/2019
Days to Decision
138 days
Submission Type
Summary

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190672
510(k) Type
Traditional
Applicant
Medtronic Navigation Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/2019
Days to Decision
138 days
Submission Type
Summary