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InSeca ARC Stylus, Aerin Console

Page Type
Cleared 510(K)
510(k) Number
K162810
510(k) Type
Traditional
Applicant
Aerin Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/11/2017
Days to Decision
97 days
Submission Type
Summary

InSeca ARC Stylus, Aerin Console

Page Type
Cleared 510(K)
510(k) Number
K162810
510(k) Type
Traditional
Applicant
Aerin Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/11/2017
Days to Decision
97 days
Submission Type
Summary