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FDA 510(k) Application Details - K060482
Device Classification Name
Apparatus, Autotransfusion
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510(K) Number
K060482
Device Name
Apparatus, Autotransfusion
Applicant
CYTORI THERAPEUTICS, INC.
3020 CALLAN ROAD
SAN DIEGO, CA 92121-1109 US
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Contact
KENNETH K KLEINHENZ
Other 510(k) Applications for this Contact
Regulation Number
868.5830
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Classification Product Code
CAC
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More FDA Info for this Product Code
Date Received
02/23/2006
Decision Date
09/28/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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