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Evolve Nitric Oxide Delivery System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222930
510(k) Type
Traditional
Applicant
Mallinckrodt Manufacturing LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/6/2023
Days to Decision
436 days
Submission Type
Summary

Evolve Nitric Oxide Delivery System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222930
510(k) Type
Traditional
Applicant
Mallinckrodt Manufacturing LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/6/2023
Days to Decision
436 days
Submission Type
Summary