MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300


Device Classification Name

centrifuges (micro, ultra, refrigerated) for clinical use

510(k) Number K021902
Device Name MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
Original Applicant
MEDTRONIC VASCULAR
7611 northland dr.
minneapolis, 
MN 
55428

Original Contact lucy tan
Regulation Number 862.2050
Classification Product Code
JQC  
Subsequent Product Code
FMF  
Date Received 06/10/2002
Decision Date 08/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No