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FlexPointer 1.5 Single Use, FlexTube 3 Single Use

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200041
510(k) Type
Special
Applicant
Fiagon GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
3/10/2020
Days to Decision
62 days
Submission Type
Summary

FlexPointer 1.5 Single Use, FlexTube 3 Single Use

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200041
510(k) Type
Special
Applicant
Fiagon GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
3/10/2020
Days to Decision
62 days
Submission Type
Summary