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AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180615
510(k) Type
Traditional
Applicant
Fresenius Kabi USA LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/4/2018
Days to Decision
271 days
Submission Type
Summary

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180615
510(k) Type
Traditional
Applicant
Fresenius Kabi USA LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/4/2018
Days to Decision
271 days
Submission Type
Summary