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
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Regulation Number 868.5830

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Classification Product Code CAC
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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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