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DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)

Page Type
Cleared 510(K)
510(k) Number
K183112
510(k) Type
Traditional
Applicant
Lumendi, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/2/2019
Days to Decision
267 days
Submission Type
Summary

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)

Page Type
Cleared 510(K)
510(k) Number
K183112
510(k) Type
Traditional
Applicant
Lumendi, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/2/2019
Days to Decision
267 days
Submission Type
Summary