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Next Generation Balloon Dilation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201115
510(k) Type
Traditional
Applicant
Acclarent Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/27/2020
Days to Decision
122 days
Submission Type
Summary

Next Generation Balloon Dilation System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201115
510(k) Type
Traditional
Applicant
Acclarent Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/27/2020
Days to Decision
122 days
Submission Type
Summary