PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM


Device Classification Name

equipment, laboratory, general purpose, labeled or promoted for a specific medical use

510(k) Number K021927
Device Name PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Original Contact lonnie witham
Regulation Number 862.2050
Classification Product Code
LXG  
Subsequent Product Code
FMF  
Date Received 06/12/2002
Decision Date 07/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No