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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
Applicant
CYTORI THERAPEUTICS, INC.
3020 CALLAN ROAD
SAN DIEGO,  CA  92121 -1109
Applicant Contact KENNETH K KLEINHENZ
Correspondent
CYTORI THERAPEUTICS, INC.
3020 CALLAN ROAD
SAN DIEGO,  CA  92121 -1109
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number868.5830
Classification Product Code
CAC  
Date Received02/23/2006
Decision Date 09/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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