Genesis Low Temperature Reusable Rigid Container System— 510(k) K153554

Substantially Equivalent

Carefusion 2200, Inc.

FDA 510(k) clearance K153554 for Genesis Low Temperature Reusable Rigid Container System, Substantially Equivalent on 2016-03-21. Applicant: Carefusion 2200, Inc..

Clearance details

Applicant: Carefusion 2200, Inc.
Product code: Code KCT
Advisory panel: General Hospital
Date received: 2015-12-14
Decision date: 2016-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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