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NeuroShield

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190246
510(k) Type
Traditional
Applicant
Monarch Bioimplants GmbH
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
5/31/2019
Days to Decision
114 days
Submission Type
Summary

NeuroShield

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190246
510(k) Type
Traditional
Applicant
Monarch Bioimplants GmbH
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
5/31/2019
Days to Decision
114 days
Submission Type
Summary