SIR-Spheres Microspheres Activity Calculator (SMAC)

System, Tomography, Computed, Emission

Sirtex Medical US Holdings Inc.

The following data is part of a premarket notification filed by Sirtex Medical Us Holdings Inc. with the FDA for Sir-spheres Microspheres Activity Calculator (smac).

Pre-market Notification Details

Device IDK202392
510k NumberK202392
Device Name:SIR-Spheres Microspheres Activity Calculator (SMAC)
ClassificationSystem, Tomography, Computed, Emission
Applicant Sirtex Medical US Holdings Inc. 300 Unicorn Park, 2nd Fl. Woburn,  MA  01801
ContactMichael P. Hanley
CorrespondentMichael P. Hanley
Sirtex Medical US Holdings Inc. 300 Unicorn Park, 2nd Fl. Woburn,  MA  01801
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2020-10-23

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