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Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222284
510(k) Type
Special
Applicant
Applied Medical Resources Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/14/2022
Days to Decision
74 days
Submission Type
Summary

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222284
510(k) Type
Special
Applicant
Applied Medical Resources Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/14/2022
Days to Decision
74 days
Submission Type
Summary