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Advanced Intermezzo Implant System

Page Type
Cleared 510(K)
510(k) Number
K191127
510(k) Type
Traditional
Applicant
MegaGen Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/8/2019
Days to Decision
162 days
Submission Type
Summary

Advanced Intermezzo Implant System

Page Type
Cleared 510(K)
510(k) Number
K191127
510(k) Type
Traditional
Applicant
MegaGen Implant Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/8/2019
Days to Decision
162 days
Submission Type
Summary