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d-Nav System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181916
510(k) Type
Traditional
Applicant
Hygieia, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/2019
Days to Decision
202 days
Submission Type
Summary

d-Nav System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181916
510(k) Type
Traditional
Applicant
Hygieia, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/2019
Days to Decision
202 days
Submission Type
Summary