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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, autotransfusion
510(k) Number K060482
Device Name CYTORI CELUTION CELL CONCENTRATION DEVICE
Original Applicant
CYTORI THERAPEUTICS, INC.
3020 callan road
san diego,  CA  92121 1109
Original Contact kenneth k kleinhenz
Regulation Number868.5830
Classification Product Code
CAC  
Date Received02/23/2006
Decision Date 09/28/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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