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HYPERION X5

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161900
510(k) Type
Traditional
Applicant
CEFLA SC
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
12/9/2016
Days to Decision
151 days
Submission Type
Summary

HYPERION X5

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161900
510(k) Type
Traditional
Applicant
CEFLA SC
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
12/9/2016
Days to Decision
151 days
Submission Type
Summary