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Sterile Products of the APTUS System

Page Type
Cleared 510(K)
510(k) Number
K232144
510(k) Type
Special
Applicant
Medartis AG
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
8/18/2023
Days to Decision
30 days
Submission Type
Summary

Sterile Products of the APTUS System

Page Type
Cleared 510(K)
510(k) Number
K232144
510(k) Type
Special
Applicant
Medartis AG
Country
Switzerland
FDA Decision
Substantially Equivalent
Decision Date
8/18/2023
Days to Decision
30 days
Submission Type
Summary