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Dissecting Balloon System

Page Type
Cleared 510(K)
510(k) Number
K182024
510(k) Type
Traditional
Applicant
Applied Medical Resources Corp.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/30/2018
Days to Decision
31 days
Submission Type
Summary

Dissecting Balloon System

Page Type
Cleared 510(K)
510(k) Number
K182024
510(k) Type
Traditional
Applicant
Applied Medical Resources Corp.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/30/2018
Days to Decision
31 days
Submission Type
Summary