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IS-III active System

Page Type
Cleared 510(K)
510(k) Number
K181138
510(k) Type
Traditional
Applicant
Neobiotech Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/3/2018
Days to Decision
156 days
Submission Type
Summary

IS-III active System

Page Type
Cleared 510(K)
510(k) Number
K181138
510(k) Type
Traditional
Applicant
Neobiotech Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/3/2018
Days to Decision
156 days
Submission Type
Summary