FDA 510(k) Application Details - K022348

Device Classification Name Apparatus, Autotransfusion

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510(K) Number K022348
Device Name Apparatus, Autotransfusion
Applicant INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact PROSIE REY-FESSLER
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Regulation Number 868.5830

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Classification Product Code CAC
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Date Received 07/19/2002
Decision Date 08/15/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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