K202392

Substantially Equivalent

SIR-Spheres Microspheres Activity Calculator (SMAC)

Applicant: Sirtex Medical US Holdings, Inc.
Product code: KPS
Advisory panel: Radiology
Date received: 2020-08-21
Decision date: 2020-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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