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DiLumen Endolumenal Interventional Platform (DiLumen)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210851
510(k) Type
Special
Applicant
Lumendi, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/21/2021
Days to Decision
30 days
Submission Type
Summary

DiLumen Endolumenal Interventional Platform (DiLumen)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210851
510(k) Type
Special
Applicant
Lumendi, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/21/2021
Days to Decision
30 days
Submission Type
Summary