Platelet Separation/Concentration System

Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

Medtronic Sofamor Danek

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Platelet Separation/concentration System.

Pre-market Notification Details

Device IDBK040068
510k NumberBK040068
Device Name:Platelet Separation/Concentration System
ClassificationCentrifuges (micro, Ultra, Refrigerated) For Clinical Use
Applicant Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TN  38132 US
Product CodeJQC  
CFR Regulation Number862.2050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-31
Decision Date2004-11-09

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