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Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221098
510(k) Type
Traditional
Applicant
Stryker Corporation
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/12/2022
Days to Decision
89 days
Submission Type
Summary

Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221098
510(k) Type
Traditional
Applicant
Stryker Corporation
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/12/2022
Days to Decision
89 days
Submission Type
Summary